Observational studyAnnals of the American Thoracic Society2019
Prospective Assessment of the Feasibility of a Trial of Low-Tidal Volume Ventilation for Patients with Acute Respiratory Failure.
Observational study in Annals of the American Thoracic Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Association between thrombocytopenia and development of acute respiratory distress syndrome.Respiratory research · 2026Pooled it
- Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial.Annals of the American Thoracic Society · 2023Trial
- Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2026.Intensive care medicine · 2026Article
- ICU Implementation Determinants and Delivery of Lung Protective Ventilation: A Multihospital Survey and Cohort Study.CHEST critical care · 2026Article
- Review
- Respiratory Therapist-Driven Mechanical Ventilation Protocol Is Associated With Increased Lung Protective Ventilation.Respiratory care · 2024Article
- Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial.CHEST critical care · 2024Article
- A Pragmatic Pilot Trial Comparing Patient-Triggered Adaptive Pressure Control to Patient-Triggered Volume Control Ventilation in Critically Ill Adults.Respiratory care · 2023Article
- What's to Be Found in the Wisdom of the Crowd?Annals of the American Thoracic Society · 2021Article
- The Epidemiology of Acute Respiratory Distress Syndrome Before and After Coronavirus Disease 2019.Critical care clinics · 2021Review
- Observational
- Variability in sedation assessment among intubated patients in the emergency department.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2021Article
- Impact of Clinician Recognition of Acute Respiratory Distress Syndrome on Evidenced-Based Interventions in the Medical ICU.Critical care explorations · 2021Article
- Implementation of an ED-based bundled mechanical ventilation protocol improves adherence to lung-protective ventilation.The American journal of emergency medicine · 2021Observational
- Use of Machine Learning to Screen for Acute Respiratory Distress Syndrome Using Raw Ventilator Waveform Data.Critical care explorations · 2021Article
- Identifying Clinical Research Priorities in Adult Pulmonary and Critical Care. NHLBI Working Group Report.American journal of respiratory and critical care medicine · 2020Article
- Emerging concepts in ventilation-induced lung injury.F1000Research · 2020Review
- Driving pressure is not associated with mortality in mechanically ventilated patients without ARDS.Critical care (London, England) · 2019Article
- Performance Measure Development, Use, and Measurement of Effectiveness Using the Guideline on Mechanical Ventilation in Acute Respiratory Distress Syndrome. An Official American Thoracic Society Workshop Report.Annals of the American Thoracic Society · 2019Review
- Epidemiology, Mechanical Power, and 3-Year Outcomes in Acute Respiratory Distress Syndrome Patients Using Standardized Screening. An Observational Cohort Study.Annals of the American Thoracic Society · 2019Observational
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Authors and funding
26 authors at 16 institutions in 2 countries.
Funding
Abstract
rationaleLow-tidal volume ventilation (LTVV; 6 ml/kg) benefits patients with acute respiratory distress syndrome and may aid those with other causes of respiratory failure. Current early ventilation practices are poorly defined.
objectivesWe observed patients with acute respiratory failure to assess the feasibility of a pragmatic trial of LTVV and to guide experimental design.
methodsWe prospectively enrolled consecutive patients with acute respiratory failure admitted to intensive care units expected to participate in the proposed trial. We collected clinical data as well as information on initial and daily ventilator settings and inpatient mortality. We estimated the benefit of LTVV using predictive linear and nonlinear models. We simulated models to estimate power and feasibility of a cluster-randomized trial of LTVV versus usual care in acute respiratory failure.
resultsWe included 2,484 newly mechanically ventilated patients (31% with acute respiratory distress syndrome) from 49 hospitals. Hospital mortality was 28%. Mean initial tidal volume was 7.1 ml/kg predicted body weight (95% confidence interval, 7.1-7.2), with 78% of patients receiving tidal volumes less than or equal to 8 ml/kg. Our models estimated a mortality benefit of 0-2% from LTVV compared with usual care. Simulation of a stepped-wedged cluster-randomized trial suggested that enrollment of 106,361 patients would be necessary to achieve greater than 90% power.
conclusionsUse of initial tidal volumes less than 8 ml/kg predicted body weight was common at hospitals participating in the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. After considering the size and budgetary requirement for a cluster-randomized trial of LTVV versus usual care in acute respiratory failure, the PETAL Network deemed the proposed trial infeasible. A rapid observational study and simulations to model anticipated power may help better design trials.
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