Métodos para fijar los tubos endotraqueales en recién nacidos
Resumen
Antecedentes
Fijar un tubo endotraqueal es un procedimiento habitual en la unidad de cuidados intensivos neonatales. La fijación adecuada del tubo es fundamental para asegurar la asistencia respiratoria eficaz del lactante además de que reduce al mínimo las complicaciones potenciales secundarias a la intervención. Con frecuencia, los métodos utilizados para fijar el tubo endotraqueal varían entre las unidades e incluso entre los profesionales sanitarios de la misma unidad neonatal.
Objetivos
Comparar los diferentes métodos de fijación del tubo endotraqueal en el recién nacido con asistencia respiratoria y los efectos sobre el riesgo de extubación accidental y otras complicaciones potenciales debidas a la inestabilidad del tubo endotraqueal.
Métodos de búsqueda
Se realizó una búsqueda bibliográfica en MEDLINE (desde 1966 hasta junio de 2013), CINAHL (desde 1982 hasta junio de 2013) y en CENTRAL en The Cochrane Library para identificar ensayos relevantes para ser analizados.
Criterios de selección
Todos los ensayos controlados aleatorios y cuasialeatorios en recién nacidos intubados para recibir asistencia respiratoria mecánica en una unidad de cuidados intensivos neonatales que compararon métodos de estabilización del tubo endotraqueal.
Obtención y análisis de los datos
Se obtuvieron datos de estudios individuales para determinar los métodos que se compararon, la metodología del ensayo y si hubo áreas de sesgo que podrían afectar significativamente los resultados de los estudios. De los estudios se evaluaron en particular el cegamiento de la asignación al azar, el cegamiento de la intervención, la completitud del seguimiento, el cegamiento de las evaluaciones de resultado y el informe selectivo.
Resultados principales
Se identificaron e incluyeron en la revisión cinco ensayos controlados aleatorios. La extubación accidental fue el resultado medido con más frecuencia (cinco estudios). Ninguno de los estudios informó la necesidad de reintubación ni la tasa de posición incorrecta del tubo; sin embargo, un estudio informó el deslizamiento del tubo endotraqueal. Se informaron otros efectos adversos como la mortalidad, la incidencia de traumatismo cutáneo perioral y necesidad de reinserción del tubo. Los cinco estudios tuvieron calidad metodológica deficiente, un tamaño pequeño, riesgos de sesgo y compararon métodos de fijación del tubo endotraqueal que fueron demasiado diferentes para poder agrupar los datos o incluirlos en un metanálisis. Estos aspectos no se informaron de manera adicional.
Conclusiones de los autores
Esta revisión destacó la necesidad de realizar estudios adicionales bien diseñados y completos sobre este procedimiento neonatal habitual. Faltan pruebas para determinar el método más eficaz y seguro para estabilizar el tubo endotraqueal en el recién nacido con asistencia respiratoria.
PICO
Resumen en términos sencillos
Métodos para fijar los tubos endotraqueales en recién nacidos
Pregunta de la revisión
Con el transcurso de los años, han existido múltiples formas diferentes de fijar el tubo endotraqueal en el recién nacido con asistencia respiratoria. Se revisaron las pruebas del método más eficaz para fijar el tubo endotraqueal en los recién nacidos que requerían ventilación mecánica. Se encontraron cinco ensayos controlados aleatorios que compararon métodos diferentes de fijación el tubo endotraqueal y que estudiaron los efectos sobre resultados como la extubación accidental.
Antecedentes
Como la atención neonatal y las tasas de supervivencia de los recién nacidos prematuros continúan mejorando, se mantendrá la necesidad permanente de intubar y proporcionar asistencia respiratoria a los recién nacidos. Éstos suelen ser los recién nacidos más enfermos de la unidad neonatal, por lo que optimizar la práctica en esta área podría repercutir sobre los resultados. El objetivo de fijar eficazmente el tubo endotraqueal es proporcionar asistencia respiratoria continua óptima, a la vez que se disminuye el riesgo de que ocurran complicaciones debidas a la inestabilidad del tubo endotraqueal.
Fecha de la búsqueda
Las pruebas están actualizadas hasta junio de 2013.
Características de los estudios
Los cinco estudios incluidos de esta revisión reclutaron pacientes de una unidad de cuidados intensivos neonatales que se intubaron y recibieron asistencia respiratoria. Las duraciones de los ensayos variaron desde el tiempo requerido para el reclutamiento de números pequeños de sujetos, hasta los diez meses. El número de participantes en los estudios varió de 30 a 203 lactantes con asistencia respiratoria.
Resultados clave
La extubación accidental fue el resultado medido en los cinco estudios y fue el resultado de interés de esta revisión. Otros resultados secundarios incluyeron traumatismo de la piel, deslizamiento del tubo y tasas de necesidad de reinserción preventiva. Los cinco estudios compararon métodos de fijación del tubo endotraqueal que fueron demasiado diferentes para poder agrupar los datos o incluirlos en un metanálisis.
Calidad de la evidencia
La calidad general de las pruebas fue baja. Las limitaciones en el diseño y la implementación fueron evidentes a diferentes grados en los cinco estudios. Ninguno de los estudios indicó si se ocultó la asignación. Debido a la naturaleza de la intervención, los estudios no fueron cegados; sin embargo, ninguno de los estudios indicó si los datos se obtuvieron de forma cegada, por lo que hubo riesgo de sesgo. Un estudio tuvo un grupo grande de recién nacidos que se excluyó del análisis, así como sesgo de publicación. Los resultados concluyentes de ensayos bien diseñados y realizados podrían ayudar a optimizar la práctica actual.
Authors' conclusions
Background
Since the 1960s, mechanical ventilation via the endotracheal tube has significantly improved overall survival of the critically ill newborn infant and, in particular, the premature infant. For this intervention to function effectively it requires the endotracheal tube, the conduit for exchanging gases, to be sufficiently stabilised. The use of uncuffed endotracheal tubes in newborns necessitates meticulous attention to the process of securing the tube. The challenges faced by neonatal staff arise from the awkward configuration of the thin plastic tube and it being secured well enough to the skin so that its movement is minimal, but not so adherent as to cause skin trauma if the tube needs to be moved or re‐secured.
Description of the condition
Poor fixation of the endotracheal tube has been reported to be the most common cause of accidental extubation (Veldman 2006). Re‐intubation following unplanned extubation can expose the infant to additional pain and trauma. With each intubation attempt there is the potential risk for local trauma to the mouth and pharynx from the laryngoscope (Ahluwalia 2005) and the vocal cords and trachea from the endotracheal tube. Skin loss secondary to repeated removal of tape adhesive can lead to infection and further pain. Ideally, these complications can be avoided if the tube is well secured after the first successful intubation.
The optimal position for the lower end of the endotracheal tube in newborn infants is midway between the larynx and the carina. As this distance can be very short, there is minimal room for error. Apart from accidental extubation when the endotracheal tube is too high in the trachea, poor fixation can lead to the tube being positioned too low resulting in bronchial intubation and subsequent lung collapse or air leak.
Many methods of endotracheal tube fixation have been employed with different levels of success and risk of complications. Some of these methods include adhesive tapes (Emami 1981a), sutures (Cussel 1974), silk ties (Andrews 2007), endotracheal tube holders (Petros 1997), umbilical cord clamps (DeJonge 1998; Loughead 2008), head restraints (Bloch 1973) and bonnets (Grammatikopoulos 2003), or a combination of these techniques (Cussel 1974). The ease and success of each method can be affected by the level of skill of the nursing and medical staff.
Some infants only require a short period of ventilation, while others may need to remain intubated for many weeks. With the advent of plastic endotracheal tubes (Shann 2003), the capability for prolonged endotracheal intubation has contributed to a significant improvement in survival of newborns, especially in the preterm infant population. Reported complications of prolonged intubation include the development of pressure areas and cosmetic deformity, airway damage, subglottic stenosis, iatrogenic cleft palate (Ahluwalia 2005), palatal grooves (Macey‐Dare 1999) and defective dentition (Angelos 1989).
Description of the intervention
Methods of tube stabilisation include but are not limited to adhesive tapes, sutures, silk ties, endotracheal tube holders, umbilical cord clamps or a combination of these techniques.
How the intervention might work
The ideal tube stabilisation method must be able to allow movement of the infant during care and minimise movement of the tube. It should also decrease the number of times the tube needs re‐taping or adjustment as each episode of tube manipulation may increase the risk of tube dislodgement. The optimal method may also differ depending on whether the infant is nasally or orally intubated.
Why it is important to do this review
There is wide variation in the methods of endotracheal tube fixation in neonates. It would be helpful to determine the most effective way to stabilise the endotracheal tube in this population.
Objectives
To compare the different methods of securing the endotracheal tube in the ventilated neonate and their effects on the risk of accidental extubation and other potential complications that can result from an unstable endotracheal tube.
Data permitting, subgroup analyses were planned to determine whether the results differed by:
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weight at time of randomisation (< 1000 g versus ≥ 1000 g);
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nasal versus oral intubation.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials of any quality and some types of non‐randomised trials (that is quasi‐randomised trials) in intubated neonates.
Types of participants
Infants admitted to the neonatal intensive care unit who required intubation for mechanical ventilation.
Types of interventions
Studies which compared different methods of endotracheal tube fixation, which may include but not necessarily be limited to the use of adhesive tapes only, the use of sutures or ties alone or in combination with tapes, endotracheal tube holders, umbilical cord clamps, the use of head restraints, the use of bonnets that encompass the head, or any other method not included in the above.
Types of outcome measures
Primary outcomes
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Accidental extubation (number of episodes per patient‐days of intubation)
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The need for re‐intubation (number of episodes per patient‐days of intubation)
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Rate of tube malposition on x‐ray (number of episodes per patient‐days of intubation)
Secondary outcomes
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Mortality (neonatal mortality and mortality during hospital admission)
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Incidence of tube re‐taping (number of episodes per patient‐days of intubation)
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Total or partial lung collapse (number of episodes per patient‐days of intubation)
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Incidence of air leak (e.g., pneumothorax, pulmonary interstitial emphysema)
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Incidence of subglottic stenosis or post‐extubation stridor
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Incidence of perioral or facial pressure areas and skin trauma
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Incidence of chronic lung disease (oxygen requirement at 28 postnatal days or oxygen requirement at 36 weeks postmenstrual age)
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Duration of hospital stay (days)
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Duration of ventilation (days and hours, or hours)
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Duration of oxygen therapy (days and hours, or hours)
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Incidence of an adverse neurodevelopmental outcome (e.g., cerebral palsy, sensorineural hearing loss, visual impairment, developmental delay) whenever measured in the primary studies
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Incidence of long‐term dentition problems (at 2, 5, 11 and 21 years of age)
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Any other clinically relevant outcomes identified in individual studies
Search methods for identification of studies
Electronic searches
See: Cochrane Neonatal Review Group search strategy
The standard search strategy for the Cochrane Neonatal Review Group was used. A search of MEDLINE (from 1950 to present), CINAHL (from 1982 to present), Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library was conducted using the following search strategy:
MeSH search terms “Infant, Newborn” OR the textwords “neonat$” or “infant$”
AND
MeSH search terms “Intubation, intratracheal” OR the textwords (“tracheal” OR “endotracheal” OR “endo‐tracheal” OR “intratracheal” OR “intra‐tracheal” OR “nasoendotracheal” OR “naso‐endotracheal”) AND (“tube” OR “intubat$”)
AND
The textwords “fix$” or “tap$” or “secur$” or “stabili$”
Searching other resources
Previous reviews (including cross references) were searched. Searches were not restricted to publications in the English language or published data.
Data collection and analysis
Data were collected from the included studies and analysed where possible using the standard methods of the Cochrane Handbook for Systematic Reviews of Interventions (http://handbook.cochrane.org/).
Selection of studies
To assess the methodological quality of the trials we used the standard methods and criteria of the Cochrane Neonatal Review Group and the Cochrane Handbook for Systematic Reviews of Interventions (http://handbook.cochrane.org/).
Assessment of risk of bias in included studies
The standard method of the Cochrane Neonatal Review Group was used with authors independently assessing the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreement by discussion.
The methodological quality of the studies was assessed using the following criteria.
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Sequence generation (checking for possible selection bias). For each included study, we categorized the method used to generate the allocation sequence as:
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low risk (any truly random process e.g., random number table, computer random number generator);
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high risk (any non‐random process e.g., odd or even date of birth, hospital or clinic record number);
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unclear risk.
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Allocation concealment (checking for possible selection bias). For each included study, we categorized the method used to conceal the allocation sequence as:
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low risk (e.g., telephone or central randomisation, consecutively numbered sealed opaque envelopes);
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high risk (e.g., open random allocation, unsealed or non‐opaque envelopes, alternation, date of birth);
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unclear risk.
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Blinding of participants and personnel (checking for performance bias). For each included study, we categorized the methods used to blind study participants and personnel from knowledge of which intervention a participant received. We categorized the methods as:
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low risk, high risk or unclear risk for participants;
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low risk, high risk or unclear risk for personnel;
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low risk, high risk or unclear risk for outcome assessors.
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Blinding of outcome assessment (checking for possible detection bias). For each included study, we categorized the methods used to blind study participants and personnel from knowledge of which intervention a participant received. Blinding was assessed separately for different outcomes or classes of outcomes. We categorized the methods as:
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low risk, high risk or unclear risk for participants;
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low risk, high risk or unclear risk for personnel;
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low risk, high risk or unclear risk for outcome assessors.
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Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations). For each included study and for each outcome, we described the completeness of the data including attrition and exclusions from the analysis. We noted whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total number of randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported or supplied by the trial authors, we re‐included missing data in the analyses. We categorized the methods as:
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low risk (< 20% missing data);
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high risk (≥ 20% missing data);
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unclear risk.
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Selective reporting bias. For each included study, we described how we investigated the possibility of selective outcome reporting bias and what we found. We assessed the methods as:
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low risk (where it was clear that all of the study’s pre‐specified outcomes and all expected outcomes of interest to the review have been reported);
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high risk (where not all the study’s pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest were reported incompletely and so cannot be used; study failed to include results of a key outcome that would have been expected to have been reported);
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unclear risk.
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Other sources of bias. For each included study, we described any important concerns we had about other possible sources of bias (e.g., whether there was a potential source of bias related to the specific study design or whether the trial was stopped early due to some data‐dependent process). We assessed whether each study was free of other problems that could put it at risk of bias, as:
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low risk, high risk or unclear risk.
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We made explicit judgements regarding whether studies were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We assessed the likely magnitude and direction of the bias and whether we considered it likely to impact on the findings. If needed, we planned to explore the impact of the level of bias through undertaking sensitivity analyses (see 'Sensitivity analysis' below).
Measures of treatment effect
For continuous variables, weighted mean differences and 95% confidence intervals would be reported. For categorical outcomes, the relative risks and 95% confidence intervals would be reported. For significant findings, the risk difference and number needed to treat with 95% confidence intervals would be reported.
For outcomes such as counts or rates (such as the number of episodes of accidental extubation per patient‐days of intubation) the data would be pooled as for continuous variables. If such methods were required, we would have used those in section 9.4.8 of the Cochrane Handbook for Systematic Reviews of Interventions (http://handbook.cochrane.org/).
Dealing with missing data
We did not contact the authors of the studies for additional information or data.
Assessment of heterogeneity
The fixed‐effect model would be used for meta‐analysis. If there were sufficient included studies, heterogeneity would be assessed using the I2 statistic.
Subgroup analysis and investigation of heterogeneity
If statistical heterogeneity was found, the authors looked for an explanation as described in the Cochrane Handbook for Systematic Reviews of Interventions (http://handbook.cochrane.org/).
Sensitivity analysis
Data permitting, a sensitivity analysis would be used to see if results differed by quality of included studies that is, adequacy of randomisation (quasi‐randomised versus randomised).
Unit of analysis
No unit of analysis issues arose. If they had arisen, we would have used the methods in section 9.3.1 of the Cochrane Handbook for Systematic Reviews of Interventions (http://handbook.cochrane.org/).
Results
Description of studies
See: Characteristics of included studies
Performing a search through PubMed, CINAHL and CENTRAL, 342 references were identified. From the title and abstract 31 studies contained relevant material and of these four met the eligibility criteria (Brown 1988; McCann 1988; McLean 1992; Volsko 1998). The remaining studies were excluded because they were not randomised or they were retrospective or case studies. One unpublished study was found during an ad hoc, unplanned Google search (Conley 1989). A total of five studies which met the eligibility criteria were included in this review.
Brown 1988 was a prospective comparison of two taping methods with or without head restraint. There were four groups of care practices, "tape method 1 with or without head restraint and tape method 2 with or without head restraint". The tape method 1 used cloth tape over dried benzoin: "Two strips of one‐inch cloth tape partially split in Y and taped to side of face, with one leg of each piece taped to tube and other leg taped to upper or lower lip". Tape method 2 used elastic tape over dried benzoin: "Elastic tape split into H, with one side taped to middle‐upper lip and other side taped to tube. Next, half inch strip of pink tape was taped from skin over one zygoma down to tube, around, then back up to other side of face". The infants were also stratified by birth weight, < 1500 g or > 1500 g. Care practices were assigned randomly during the six month study. Of the 203 infants enrolled, 71 patients (35%) were not included in the analysis because of lack of head restraint, wrong taping method, nasal intubation or paralysis and sedation. After the fourth month of the study, analysis of the data showed that taping method 2 was significantly better, so only this method was used for the remaining two months and infants were randomised to receive head restraint or not. The rates of accidental extubation of the four randomised groups were calculated on a total of 142 patients.
McCann et al (McCann 1988) was a two phase study designed to compare three methods of endotracheal tube stabilization. Phase 1 randomly selected participants for one of three taping methods. Method 1 involved "HSC Tapes" (HSCT), the name given for the existing taping method of adhesive tape with string supports. Method 2 involved "HSCT plus suture", which meant a sutured strip of adhesive bandage was applied to the neonate's upper lip in a moustache fashion, then the suture was inserted vertically through both sides of the endotracheal tube and secured with HSCT. Method 3 involved "waterproof tapes plus suture", which meant the adhesive bandage was applied as described in method 2, and two pieces of waterproof tape cut in a trouser leg pattern were applied to secure the endotracheal tube. Phase 2 selected participants for two taping methods. The taping methods were method 2 and method 3 as described in Phase 1. One hundred and twenty‐five patients were collected over a 10 month period, each phase lasting five months.
McLean et al (McLean 1992) conducted a study to test whether a pectin‐based barrier layer used to secure endotracheal tube taping could reduce the frequency of changing tapes and skin trauma. Infants who required oral endotracheal intubation were randomly assigned to one of three groups: a control group of 27 infants for whom transparent tape (Dermiclear®) was used as a base layer to secure the endotracheal tube, an experimental group of 27 infants for whom a skin barrier (Hollihesive®) was used as a base layer, and an experimental group of 29 infants for whom a hydrocolloid dressing (Duoderm®) was used as a base layer.
Volsko et al (Volsko 1998) conducted a pilot study comparing two methods of securing an endotracheal tube with infants requiring intubation and ventilation. Infants were randomised to either a facial scaffold device (Neobar® (Neotech Products Inc.)) or conventional tape. The facial scaffold device (Neobar®) is a small plastic arch with adhesive cheek pads. The endotracheal tube was taped to the arch rather than to the patient's upper lip. No additional fixatives were used under the cheek pads. The conventional taping method required the administration of tincture of benzoin to the area of the upper lip prior to the application of a piece of adhesive bandage (Elastoplast®). A piece of cloth tape was wrapped around the tube twice and anchored to the opposite side of the face, over the adhesive bandage (Elastoplast®). This was repeated with a second piece of tape which started at the opposite side of the face. Thirty‐two infants were randomised to the facial scaffold device (Neobar®) (14) or tape (18). This study was only available in abstract form. A complete published version was not located.
Conley 1989 conducted a prospective study of infants who required mechanical ventilation. Infants were randomly assigned (by coin toss) to the experimental and control groups. The sample consisted of 30 preterm infants aged at least 27 weeks gestation (born or corrected) who required mechanical ventilation. Infants who were less than 27 weeks, paralysed, or who were intubated for less than six days were excluded from the study. The experimental group used an endotracheal tube holder, a product of Respiratory Support Products, Inc. of California, which consists of a slip lock, a cylinder and a holder. The endotracheal tube was held in position within the cylinder by the slip lock which secured it. The holder has an adhesive surface which is applied to the patient's face. The control group had their endotracheal tubes secured with Dermiclear tape as a base layer and two strips of cloth tape split in a Y. The inferior arm of the Y of the first cloth tape was wrapped clockwise around the tube and the second was wrapped counter‐clockwise around the tube.
Risk of bias in included studies
All of the included studies randomised the individual patient. It was not stated how the random sequence lists were generated and whether randomisation lists were concealed in all studies except one (Conley 1989). Treatment could not be blinded due to the nature of the study. All patients were accounted for in two studies (McCann 1988; McLean 1992). Brown 1988 had a large exclusion list (after randomisation, due to various reasons including inconsistency in intervention methods provided). Conley 1989 reported that nine additional participants were enrolled in the traditional taping group but were extubated early and analysis was not by intention to treat. It was not stated in any of the five studies whether the groups were treated equally apart from the interventions. The treatment groups appeared similar at the start of the trial in McLean 1992 and Conley 1989, but it was unclear whether this was the case in Brown 1988, McCann 1988 or Volsko 1998. The methodological quality of McCann et al (McCann 1988), Volsko et al (Volsko 1998), McLean et al (McLean 1992) and Conley (Conley 1989) was average. The methodological quality of Brown (Brown 1988) was poor.
Effects of interventions
The results of the five included studies in this review could not be meta‐analysed because the studies were too heterogeneous and the methods of securing the endotracheal tube were different between studies. The following are the results of individual studies.
Primary outcomes
Accidental extubation
Brown (Brown 1988) reported an overall accidental extubation rate of 4.4 per 100 days of intubation, and 4.2 per 100 days when results were calculated excluding patients with poor compliance to the protocol. Two different taping methods were compared, with and without head restraint. Tape method 1 used cloth tape over dried benzoin: "Two strips of one‐inch cloth tape partially split in Y and taped to side of face, with one leg of each piece taped to tube and other leg taped to upper or lower lip". Tape method 2 used elastic tape over dried benzoin: "Elastic tape split into H, with one side taped to middle‐upper lip and other side taped to tube. Next, half inch strip of pink tape was taped from skin over one zygoma down to tube, around, then back up to other side of face". Taping method 1 had a rate of 6.4 and 6.7 extubation episodes per 100 intubation days with or without head restraint, respectively. In comparison, taping method 2 had a rate of 2.6 and 2.5 extubation episodes per 100 intubation days with or without head restraint, respectively. There was no difference in extubation rate between infants with a head restraint and those without. A statistically significant difference (P < 0.001) was found between taping method 1 versus 2 with no head restraint, and for taping method 1 versus 2 with head restraint (P < 0.03).
McCann (McCann 1988) reported, in Phase 1 of the study, the accidental extubation rates for the three methods: method 1 had 11 accidental extubations per 100 tube days, whereas method 2 and method 3 both had four accidental extubations per 100 tube days. The overall rate of accidental extubation decreased during the study period when compared to accidental extubation rates prior to the study. In Phase 1, the overall rate of accidental extubation decreased by 15%. In Phase 2, the overall rate of accidental extubation decreased by 50%.
Volsko et al (Volsko 1998) reported an extubation rate of 4.8 per 100 ventilation days for the facial scaffold device (Neobar®) method compared with 15.6 per 100 ventilation days for the tape method. There was no significant difference in extubations per 100 ventilator days between the two interventions.
McLean et al (McLean 1992) reported no statistically significant difference in the number of self‐extubations among the intervention groups. It was unclear whether the rate was calculated per 100 ventilation days.
Conley (Conley 1989) observed the number of accidental extubations in a six day study period. There were 12 accidental extubations in the traditional taping method group compared to one accidental extubation in the endotracheal tube holder group, a statistically significant difference (P = 0.0082). Thus the extubation rate for the traditional taping group was 200 extubations per 100 ventilation days compared to the 16.7 accidental extubations per 100 ventilation days in the tube holder group.
The need for re‐intubation
No study reported this.
Rate of tube malposition on x‐ray
No study reported this.
Secondary outcomes
Mortality
Brown et al (Brown 1988) reported a 16.3% mortality rate in those intubated and randomised, however there was a 35% exclusion rate and it was unclear how many of those who died were in this group.
Conley 1989 reported that one infant died in each group, one from peritoneal perforation in the tube holder group and the other from cardiorespiratory failure in the traditional taping group. It was not reported if these deaths were related to an accidental extubation.
No other studies in this review reported on mortality.
Degree of tube slippage (added post hoc)
Conley 1989 reported significantly more endotracheal tube slippage in the traditional taping method compared to the endotracheal tube holder (P = 0.044).
Incidence of tube re‐taping
Conley 1989 reported no significant differences between groups regarding the frequency of re‐stabilization of the endotracheal tube.
McCann 1988 reported a prophylactic re‐taping rate < 1% for all three methods described.
McLean 1992 reported that the rate of stabilization layer changes in the hydrocolloid dressing (Duoderm®) group of 9.79/29 was statistically significantly less than the skin barrier (Hollihesive®) group's rate of 13.67/27 and the transparent tape (Dermiclear®) group's rate of 11.7/27.
Total or partial lung collapse
No study reported this.
Incidence of air leak
No study reported this.
Incidence of subglottic stenosis or post‐extubation stridor
No study reported this.
Incidence of perioral or facial pressure areas and skin trauma
Brown (Brown 1988) reported no difference in skin abrasion between the two different taping methods.
Volsko et al (Volsko 1998) reported that the facial scaffold device (Neobar®) was superior to tape in the categories of skin condition.
McLean et al (McLean 1992) reported no difference in lip intactness and lip colour for the different base layers.
Incidence of chronic lung disease
No study reported this.
Duration of hospital stay
No study reported this.
Duration of ventilation
No study reported this.
Duration of oxygen therapy
No study reported this.
Incidence of an adverse neurodevelopmental outcome
No study reported this.
Incidence of long‐term dentition problems
No study reported this.
Other clinically relevant outcomes identified in individual studies
Volsko et al (Volsko 1998) reported that the facial scaffold device (Neobar®) was superior to tape in the ease of verifying endotracheal placement.
Subgroups
Weight at time of randomisation (< 1000 g versus ≥ 1000 g)
No studies stratified for < 1000 g versus > 1000 g. However, Brown 1988 stratified the infants by birthweight < 1500 g and > 1500 g and care was assigned randomly for each of the two weight groups. Twenty‐eight (23%) of the 122 infants with a birthweight > 1500 g had accidental extubations, while 34 (42%) of the 81 infants with a birthweight < 1500 g had accidental extubations.
Nasal versus oral intubation
No study analysed this.
Discussion
Summary of main results
The diversity in endotracheal stabilizing techniques that were compared in the five included studies precluded collation of the data for meta‐analysis. Three out of the five studies included in this review appeared to be significantly underpowered, however this is not surprising given each of the three studies did not have a sample size calculation. McCann 1988 recruited a larger number of participants but it was unclear as to whether the decrease in accidental extubations between fixation methods was statistically significant due to poor reporting. Brown 1988 recruited a larger number of participants and did show a statistically significant difference between taping method 1 versus method 2 (P < 0.001) without head restraint and with head restraint (P < 0.03). However, the large group (35%) excluded from the results and lack of intention‐to‐treat analysis confers a serious analytical and reporting bias, rendering the results questionable. Conley 1989 found a statistically significant difference in accidental extubation between the control and tube holder groups (P = 0.0082); the extubation rate for the traditional taping group is 200 extubations per 100 ventilation days compared to the 16.7 accidental extubations per 100 ventilation in the tube holder group. However, as reported in the methodology, nine enrolled participants were excluded from the analysis because they were extubated prior to completing the six days required for study inclusion, decidedly raising questions about the study validity.
Quality of the evidence
Overall, the studies were of poor quality, underpowered, poorly reported or contained serious risks of bias. More well designed randomised controlled trials with a larger number of participants are required.
Potential biases in the review process
There were no potential biases in the review process.
Future studies
Given the lack of reliable evidence to support the use of one particular method over any other it would seem prudent for individual neonatal units to use the quality improvement cycle for clinical problem solving through evidence generation, synthesis, implementation, and evaluation (Henderson‐Smart 2003). This would aid the identification and clarification of the best technique for use in their own unit. There would then be potential for comparing this method to any new proposed methods in a randomised controlled trial.
