Prospective, randomized, controlled clinical trial comparing traditional versus reduced tidal volume ventilation in acute respiratory distress syndrome patients
Abstract
OBJECTIVE: To assess the safety and potential efficacy of a mechanical ventilation strategy designed to reduce stretch-induced lung injury in acute respiratory distress syndrome. DESIGN: Prospective, randomized, controlled clinical trial. SETTING: Eight intensive care units in four teaching hospitals. PATIENTS: Fifty-two patients with acute respiratory distress syndrome. INTERVENTIONS: Traditional tidal volume patients: tidal volume 10-12 mL/kg ideal body weight, reduced if inspiratory plateau pressure was > 55 cm H2O (7.3 kPa). Small tidal volume patients: tidal volume 5-8 mL/kg ideal body weight, to keep plateau pressure < 30 cm H2O (4.0 kPa). MEASUREMENTS AND MAIN RESULTS: Mean tidal volumes during the first 5 days in traditional and small tidal volume patients were 10.2 and 7.3 mL/kg, respectively (p < .001), with mean plateau pressure = 30.6 and 24.9 cm H2O (3.3 kPa), respectively (p < .001). There were no significant differences in requirements for positive end-expiratory pressure or FIO2, fluid intakes/outputs, requirements for vasopressors, sedatives, or neuromuscular blocking agents, percentage of patients that achieved unassisted breathing, ventilator days, or mortality. CONCLUSIONS: The reduced tidal volume strategy used in this study was safe. Failure to observe beneficial effects of small tidal volume ventilation treatment in important clinical outcome variables may have occurred because a) the sample size was too small to discern small treatment effects; b) the differences in tidal volumes and plateau pressures were modest; or c) reduced tidal volume ventilation is not beneficial.
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These three RCTs compared a strategy of low tidal volume and limited plateau pressure with a strategy using higher tidal volume and plateau pressure; pooled data suggest reduced mortality (RR 0.83; 95% CI 0.70-0.97) and more ventilator-free days (MD 1.8 days; 95% CI 0.35-3.25) in patients managed with low plateau pressures.
“These three RCTS compared a strategy of low tidal volume and limited plateau pressure with a strategy using higher tidal volume and plateau pressure; pooled data suggest reduced mortality (RR 0.83; 95% CI 0.70–0.97) and more ventilator-free days (MD 1.8 days; 95% CI 0.35–3.25) in patients managed with low plateau pressures.”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [427]
Several multicentre RCTs have been performed in patients with established ARDS to evaluate the effects of limiting inspiratory pressure through moderation of tidal volume.
“Several multicentre RCTs have been performed in patients with established ARDS to evaluate the effects of limiting inspiratory pressure through moderation of tidal volume [424–427].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [427]
The 3 RCTs that guide the plateau pressure recommendation enrolled patients using the American-European Consensus Criteria Definition for Acute Lung Injury and ARDS, whereas the current document uses the 2012 Berlin definition.
“Of note, the 3 RCTs that guide this recommendation [424, 426, 427] enrolled patients using the criteria from the American-European Consensus Criteria Definition for Acute Lung Injury and ARDS [422] whereas the current document use the 2012 Berlin definition and the terms mild, moderate, and severe ARDS (PaO2/FiO2 ≤ 300, ≤ 200, and ≤ 100 mm Hg, respectively) [423].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [427]
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- Authors
- Brower, R. G., Shanholtz, C. B., Fessler, H. E., Shade, D. M., White, P., Wiener, C. M., Teeter, J. G., Dodd-o, J. M., Almog, Y., & Piantadosi, S.
- Affiliations
- Johns Hopkins University (US)
- University of Maryland, Baltimore (US)
- Venue
- Critical Care Medicine
- Published
- 1999-08
- Volume
- 27
- Issue
- 8
- Pages
- 1492-1498
- ISSN
- 0090-3493 (ISSN-L)
- OpenAlex
- W2009713463
- Cited by
- 575
- References
- 30
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 8 · 2023: 5 · 2022: 25 · 2021: 19 · 2020: 14 · 2019: 12 · 2018: 17 · 2017: 19 · 2016: 12 · 2015: 13 · 2014: 16 · 2013: 18 · 2012: 23
- FWCI
- 22.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Critical Care Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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 respiratory distress syndrome, mechanical ventilation, ventilator-induced lung injury, positive end-expiratory pressure, mortality, vasopressors, sedation, neuromuscular blockade
- MeSH terms
- Adult, Blood Gas Analysis, Body Weight, Clinical Protocols, Female, Humans, Length of Stay, Male, Middle Aged, Oxygen, Positive-Pressure Respiration, Prospective Studies, Pulmonary Gas Exchange, Respiratory Distress Syndrome, Tidal Volume, Hospital Mortality
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