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Ventilator-Induced Lung Injury

Nicola Petrucci, MD
[+] Author Affiliations

Phil B. Fontanarosa, MDDeputy Editor: IndividualAuthor
Stephen J. Lurie, MD, PhDFishbein Fellow: IndividualAuthor

Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

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JAMA. 2000;283(8):1003-1004. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-8-jlt0223
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To the Editor: Dr Ranieri and colleagues1 demonstrated that among patients affected by acute respiratory distress syndrome (ARDS), those receiving mechanical ventilation with conventional ventilation showed significantly higher levels of pulmonary and systemic mediators compared with patients who received ventilation with a "lung-protective" strategy. The authors concluded that "mechanical ventilation can induce a cytokine response that may be attenuated by a strategy to minimize overdistension and recruitment/derecruitment of the lung." The data suggest that ventilator-induced lung injury also can result in systemic inflammation and associated multiple organ failure.

However, I have several concerns about the study's methods. The authors reported that 7 patients dropped out; these patients were not included in the follow-up. Simply ignoring all patients that withdraw from a clinical trial will bias the results, usually in favor of the intervention. It should be standard practice to analyze the results of clinical trials on an intent-to-treat basis.2 The authors also reported the results in terms of mean (SD), without describing the absolute number of patients with increases in levels of each mediator in each group. It is difficult to extract these numbers from the figures in the article. This way of presenting the results does not allow the reader to compute the risk of outcome event in both groups and it does not describe the clinical impact of the lung-protective strategy in terms of "lungs saved from biotrauma," which remains a surrogate end point.3 Finally, the authors reported only P values and did not provide confidence intervals. Thus, it cannot be established how precise the estimate of the treatment effect was and how likely the results are to be replicable.4

REFERENCES

Ranieri  VM, Suter  PM, Tortorella  C.  et al.  Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1999;282:54-61.
Stewart  LA, Parmar  MK. Bias in the analysis and reporting of randomized controlled trials. Int J Health Technol Assess. 1996;12:264-275.
Begg  C, Cho  M, Eastwood  S.  et al.  Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637-639.
Guyatt  G, Jaeschke  R, Heddle  N, Cook  D, Shannon  H, Walter  S. Basic statistics for clinicians, II: interpreting study results: confidence intervals. CMAJ. 1995;152:169-173.

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Ranieri  VM, Suter  PM, Tortorella  C.  et al.  Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1999;282:54-61.
Stewart  LA, Parmar  MK. Bias in the analysis and reporting of randomized controlled trials. Int J Health Technol Assess. 1996;12:264-275.
Begg  C, Cho  M, Eastwood  S.  et al.  Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637-639.
Guyatt  G, Jaeschke  R, Heddle  N, Cook  D, Shannon  H, Walter  S. Basic statistics for clinicians, II: interpreting study results: confidence intervals. CMAJ. 1995;152:169-173.
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