Effects of a Clinical Trial on Mechanical Ventilation Practices in Patients with Acute Lung Injury
Open accessAbstract
Rationale: In a clinical trial by the Acute Respiratory Distress Syndrome Network (ARDSNet), mechanical ventilation with tidal volumes of 6 ml/kg decreased mortality from acute lung injury. However, interpretations of these results generated controversy and it was unclear if this trial would change usual-care practices. Objectives: First, to determine if clinical practices at ARDSNet hospitals changed after the tidal volume trial. Second, to determine if tidal volume and plateau pressure (Pplat) within 48 hours before randomization affected hospital mortality in patients subsequently managed with 6 ml/kg predicted body weight (PBW). Methods: We used preenrollment data from 2,451 patients enrolled in six trials (1996–2005) to describe changes in tidal volume over time. We used logistic regression to determine if preenrollment tidal volume or Pplat affected mortality. Measurements and Main Results: Median preenrollment tidal volume decreased from 10.3 ml/kg PBW (range, 4.3–17.1) during the tidal volume trial (1996–1999) to 7.3 ml/kg PBW (range, 3.9–16.2) after its completion (P < 0.001). Preenrollment tidal volume was not associated with mortality (P = 0.566). The odds of death increased multiplicatively with each cm H2O of preenrollment Pplat (P < 0.001) (e.g., the odds of death was 1.37 times greater when preenrollment Pplat increased by 10 cm H2O). Conclusions: Physicians used lower tidal volumes after publication of the tidal volume trial. Preenrollment Pplat was strongly associated with mortality, and may reflect disease severity independent of tidal volume. Pplat measured early in the course of acute lung injury, after accounting for tidal volume, is a respiratory system–specific value with strong prognostic significance.
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Several meta-analyses suggest decreased mortality in patients with a pressure-and volume-limited strategy for established ARDS.
“Several meta-analyses suggest decreased mortality in patients with a pressure-and volume-limited strategy for established ARDS (353,354).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [353]
The Abstract reports that an ARDSNet trial found lower hospital mortality with lower tidal volumes, and the Discussion links early plateau pressure to mortality. But this paper studies changes in ventilation practice, not the results of several meta-analyses, and it does not establish a mortality benefit for a combined pressure- and volume-limited strategy in established ARDS. (LLM, conf=0.85)
Experimental — accuracy not yet measuredA retrospective study suggested that tidal volumes should be lowered even with plateau pressures ≤ 30 cm H2O because lower plateau pressures were associated with reduced hospital mortality.
“A retrospective study suggested that tidal volumes should be lowered even with plateau pressures ≤ 30 cm H2O [431] because lower plateau pressures were associated with reduced hospital mortality [432].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [432]
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- Authors
- Checkley, W., Brower, R., Korpak, A., & Thompson, B. T.
- Affiliations
- Johns Hopkins University (US)
- Harvard University (US)
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-06-01
- Volume
- 177
- Issue
- 11
- Pages
- 1215-1222
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- PMC
- PMC2408439
- OpenAlex
- W2021668188
- Cited by
- 104
- References
- 41
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 6 · 2020: 3 · 2019: 6 · 2018: 3 · 2017: 7 · 2016: 7 · 2015: 9 · 2014: 7 · 2013: 17 · 2012: 7
- FWCI
- 6.36
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- American Journal of Respiratory and Critical Care Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Thoracic Society
- National Institutes of Health (5f32hl090179-02, n01hr016146-000, NO1-HR-46046-64)
- National Heart, Lung, and Blood Institute (N01-HR46046-64, N01-HR-16146-54, 1F32HL090179-01)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Nosocomial Infections in ICU
- Keywords
- acute lung injury, mechanical ventilation, tidal volume, plateau pressure, ARDSNet, clinical practice change, in-hospital mortality, prognostic factors, disease severity, ventilator-induced lung injury
- MeSH terms
- Airway Resistance, Clinical Trials as Topic, Humans, Practice Patterns, Physicians', Respiration, Artificial, Respiratory Distress Syndrome, Retrospective Studies, Tidal Volume, Cohort Studies, Logistic Models, Odds Ratio, Hospital Mortality
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