High‐frequency oscillatory ventilation versus conventional ventilation for acute respiratory distress syndrome

Sachin Sud; Maneesh Sud; Jan O Friedrich; Hannah Wunsch; Maureen O Meade; Niall D Ferguson; Neill KJ Adhikari

doi:10.1002/14651858.CD004085.pub4

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Figure 1

Study flow diagram for the updated literature search (from 2011 to Dec 2015, see also Results of the search)

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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 3

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 4

Forest plot of comparison: 1 Mortality, outcome: 1.1 Hospital or 30‐day mortality. (HFO = high frequency oscillation, CMV = conventional mechanical ventilation)

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Figure 5

Forest plot of comparison: 2 Adverse events, outcome: 2.1 Treatment failure (intractable hypoxia, hypotension, acidosis, hypercapnoea requiring discontinuation of study intervention). (HFO = high frequency oscillation, CMV = conventional mechanical ventilation)

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Analysis 1.1

Comparison 1 Mortality, Outcome 1 Hospital or 30‐day mortality.

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Analysis 1.2

Comparison 1 Mortality, Outcome 2 Hospital or 30‐day mortality (Bollen 2005 and Mentzelopoulos 2012 participants lost to follow‐up censored).

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Analysis 1.3

Comparison 1 Mortality, Outcome 3 Hospital or 30‐day mortality (Shah 2004 post‐randomization withdrawals included).

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Analysis 1.4

Comparison 1 Mortality, Outcome 4 Hospital or 30‐day mortality: adult versus paediatric trials.

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Analysis 1.5

Comparison 1 Mortality, Outcome 5 Hospital or 30‐day mortality: lung‐protective ventilation mandatory vs non‐mandatory.

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Analysis 1.6

Comparison 1 Mortality, Outcome 6 Hospital or 30‐day mortality (trials with low risk of bias).

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Analysis 2.1

Comparison 2 Ventilator dependency, Outcome 1 Duration of mechanical ventilation.

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Analysis 2.2

Comparison 2 Ventilator dependency, Outcome 2 Ventilator‐free days.

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Analysis 3.1

Comparison 3 Adverse events, Outcome 1 Treatment failure (intractable hypoxia, hypotension, acidosis, hypercapnoea requiring discontinuation of study intervention).

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Analysis 3.2

Comparison 3 Adverse events, Outcome 2 Barotrauma.

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Analysis 3.3

Comparison 3 Adverse events, Outcome 3 Hypotension.

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Analysis 3.4

Comparison 3 Adverse events, Outcome 4 Hypotension (Shah included).

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Analysis 3.5

Comparison 3 Adverse events, Outcome 5 ETT obstruction.

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Analysis 4.1

Comparison 4 Physiological endpoints (ratio of means), Outcome 1 PaO₂/FiO₂ (ratio of means).

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Analysis 4.2

Comparison 4 Physiological endpoints (ratio of means), Outcome 2 Oxygenation index (ratio of means).

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Analysis 4.3

Comparison 4 Physiological endpoints (ratio of means), Outcome 3 PaCO₂ (ratio of means).

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Analysis 4.4

Comparison 4 Physiological endpoints (ratio of means), Outcome 4 Mean airway pressure (ratio of means).

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Summary of findings for the main comparison. High‐frequency oscillation versus conventional ventilation for the treatment of acute respiratory distress syndrome


Patient or population: people with Acute Respiratory Distress Syndrome Settings: Critical Care Unit Intervention: High‐fFrequency oscillation Comparison: Conventional mechanical ventilation
Outcomes**	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Conventional Mechanical Ventilation	High Frequency Oscillation
Mortality (at 30 days or until hospital discharge)	Medium risk population¹		RR 0.92 (0.72 to 1.16)	1779 (8 studies)	⊕⊝⊝⊝ very low^2,3,4,5,6
	470 per 1000	432 per 1000 (338 to 545)
Mortality (at 6 months)	Medium risk population		RR 0.79 (0.58 to 1.08)	148 (1 study)	⊕⊝⊝⊝ very low^2,4,5
	590 per 1000	466 per 1000 (342 to 637)
Treatment failure	Medium risk population¹		RR 0.64 (0.48 to 0.85)	956 (6 studies)	⊕⊝⊝⊝ very low^2,4,5,7
	190 per 1000	122 per 1000 (91 to 162)
Duration of mechanical ventilation days. Scale from: 14 to 22	The mean duration of mechanical ventilation in the control groups was 17.1	The mean duration of mechanical ventilation in the intervention groups was 0.59 higher (1.09 lower to 2.28 higher)		1142 (5 studies)	⊕⊝⊝⊝ very low^4,5
Barotrauma	Medium risk population¹		RR 0.82 (0.51 to 1.32)	951 (7 studies)	⊕⊝⊝⊝ very low^2,4,5,7
	131 per 1000	121 per 1000 (67 to 173)
Hypotension	Medium risk population¹		RR 1.02 (0.54 to 1.90)	392 (4 studies)	⊕⊝⊝⊝ very low^2,4,5,7
	381 per 1000	389 per 1000 (206 to 724)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; ** Not shown:ventilator‐free days (very low quality ^2,3,4,5, pooled analysis not performed due to extreme heterogeneity), endotracheal tube obstruction (very low quality^2,4,5, pooled analysis not performed because all events occurred in one study), non‐clinical endpoints (i.e. physiologic endpoints, for example mean airway pressure, because these are not patient‐important outcomes).
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹The basis of the assumed risk is the median risk in the control groups across trials. ²Downgraded for serious methodologic limitations (blinding was not possible in all studies; cross‐overs between treatment groups > 10% occurred in 3 trials; post‐randomization withdrawals ranging from 1.4% ‐ 17% occurred in 3 trials). ³Downgraded for inconsistency (moderate or high statistical heterogeneity). ⁴Downgraded for serious indirectness in the comparator (5 out of 10 trials included in this systematic review did not mandate low tidal volume conventional ventilation in participants who received conventional mechanical ventilation). ⁵Downgraded for imprecision (wide confidence intervals which include no benefit, and/or appreciable harm or benefit). With the exception of hospital or 30‐day mortality, the number of outcome events was low (i.e. fewer than 300). ⁶Although the event rate exceeded 300, and the sample size exceeded the optimal information size of 1290 (assuming alpha 0.05, beta 0.10, a baseline risk of death of 45%, and a 9% absolute reduction in risk), confidence intervals were wide and included no benefit (i.e. RR = 1) as well as both meaningful benefit and harm. We therefore downgraded this outcome due to serious imprecision. ⁷Downgraded for serious indirectness in the outcome (variable definition of treatment failures, hypotension, and barotrauma across studies).

Summary of findings for the main comparison. High‐frequency oscillation versus conventional ventilation for the treatment of acute respiratory distress syndrome

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Comparison 1. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital or 30‐day mortality Show forest plot	8	1779	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.72, 1.16]

2 Hospital or 30‐day mortality (Bollen 2005 and Mentzelopoulos 2012 participants lost to follow‐up censored) Show forest plot	8	1775	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.73, 1.16]

3 Hospital or 30‐day mortality (Shah 2004 post‐randomization withdrawals included) Show forest plot	8	1784	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.73, 1.16]

4 Hospital or 30‐day mortality: adult versus paediatric trials Show forest plot	8	1779	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.72, 1.16]

4.1 Adult trials	6	1705	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.71, 1.21]
4.2 Paediatric trials	2	74	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.44, 1.43]
5 Hospital or 30‐day mortality: lung‐protective ventilation mandatory vs non‐mandatory Show forest plot	8	1779	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.72, 1.16]

5.1 Lung‐protective ventilation not mandatory	4	1062	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.77, 1.15]
5.2 Lung‐protective ventilation mandatory	4	717	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.47, 1.53]
6 Hospital or 30‐day mortality (trials with low risk of bias) Show forest plot	3	959	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.68, 1.18]

Comparison 1. Mortality

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Comparison 2. Ventilator dependency

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Duration of mechanical ventilation Show forest plot	5	1142	Mean Difference (IV, Random, 95% CI)	0.59 [‐1.09, 2.28]

2 Ventilator‐free days Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 2. Ventilator dependency

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Comparison 3. Adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure (intractable hypoxia, hypotension, acidosis, hypercapnoea requiring discontinuation of study intervention) Show forest plot	6	956	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.48, 0.85]

2 Barotrauma Show forest plot	7	951	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.51, 1.32]

3 Hypotension Show forest plot	4	392	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.54, 1.90]

4 Hypotension (Shah included) Show forest plot	5	420	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.61, 1.66]

5 ETT obstruction Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 3. Adverse events

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Comparison 4. Physiological endpoints (ratio of means)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PaO₂/FiO₂ (ratio of means) Show forest plot	8		Ratio of Means (Random, 95% CI)	Subtotals only

1.1 Day 1	8	1156	Ratio of Means (Random, 95% CI)	1.26 [1.15, 1.38]
1.2 Day 2	6	1031	Ratio of Means (Random, 95% CI)	1.18 [1.04, 1.35]
1.3 Day 3	6	881	Ratio of Means (Random, 95% CI)	1.21 [1.09, 1.35]
2 Oxygenation index (ratio of means) Show forest plot	7		Ratio of Means (Random, 95% CI)	Subtotals only

2.1 Day 1	7	423	Ratio of Means (Random, 95% CI)	1.10 [0.97, 1.25]
2.2 Day 2	6	375	Ratio of Means (Random, 95% CI)	1.06 [0.89, 1.26]
2.3 Day 3	6	330	Ratio of Means (Random, 95% CI)	1.05 [0.85, 1.29]
3 PaCO₂ (ratio of means) Show forest plot	10		Ratio of Means (Random, 95% CI)	Subtotals only

3.1 Day 1	10	1767	Ratio of Means (Random, 95% CI)	0.96 [0.87, 1.05]
3.2 Day 2	8	1587	Ratio of Means (Random, 95% CI)	0.93 [0.81, 1.06]
3.3 Day 3	7	920	Ratio of Means (Random, 95% CI)	1.00 [0.88, 1.14]
4 Mean airway pressure (ratio of means) Show forest plot	9		Ratio of Means (Random, 95% CI)	Subtotals only

4.1 Day 1	9	985	Ratio of Means (Random, 95% CI)	1.30 [1.26, 1.35]
4.2 Day 2	7	888	Ratio of Means (Random, 95% CI)	1.25 [1.19, 1.31]
4.3 Day 3	6	338	Ratio of Means (Random, 95% CI)	1.16 [1.06, 1.27]

Comparison 4. Physiological endpoints (ratio of means)

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