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Prospective Assessment of the Feasibility of a Trial of Low-Tidal Volume Ventilation for Patients with Acute Respiratory Failure.

TitleProspective Assessment of the Feasibility of a Trial of Low-Tidal Volume Ventilation for Patients with Acute Respiratory Failure.
Publication TypeJournal Article
Year of Publication2019
AuthorsLanspa MJ, Gong MNg, Schoenfeld DA, Lee KTiffany, Grissom CK, Hou PC, Serpa-Neto A, Brown SM, Iwashyna TJ, Yealy DM, Hough CL, Brower RG, Calfee CS, Hyzy RC, Matthay MA, Miller RR, Steingrub JS, B Thompson T, Miller CD, Clemmer TP, Hendey GW, Huang DT, Mathews KS, Qadir N, Tidswell M
JournalAnn Am Thorac Soc
Volume16
Issue3
Pagination356-362
Date Published2019 Mar
ISSN2325-6621
Abstract

<p><b>RATIONALE: </b>Low-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.</p><p><b>OBJECTIVES: </b>We observed patients with acute respiratory failure to assess the feasibility of a pragmatic trial of LTVV and to guide experimental design.</p><p><b>METHODS: </b>We 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.</p><p><b>RESULTS: </b>We 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.</p><p><b>CONCLUSIONS: </b>Use 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.</p>

DOI10.1513/AnnalsATS.201807-459OC
Alternate JournalAnn Am Thorac Soc
PubMed ID30407869
PubMed Central IDPMC6394119
Grant ListU01 HL123018 / HL / NHLBI NIH HHS / United States
U01 HL123031 / HL / NHLBI NIH HHS / United States
U01 HL123020 / HL / NHLBI NIH HHS / United States
U01 HL122989 / HL / NHLBI NIH HHS / United States
U01 HL123009 / HL / NHLBI NIH HHS / United States
U01 HL123004 / HL / NHLBI NIH HHS / United States
U01 HL123008 / HL / NHLBI NIH HHS / United States
U01 HL123022 / HL / NHLBI NIH HHS / United States
U01 HL123023 / HL / NHLBI NIH HHS / United States
U01 HL123027 / HL / NHLBI NIH HHS / United States
U01 HL122998 / HL / NHLBI NIH HHS / United States
U01 HL123033 / HL / NHLBI NIH HHS / United States
U01 HL123010 / HL / NHLBI NIH HHS / United States