Michael J Lanspa1,2, Michelle Ng Gong3, David A Schoenfeld4,5, Kathleen Tiffany Lee4,5, Colin K Grissom1,2, Peter C Hou6, Ary Serpa-Neto7, Samuel M Brown1,2, Theodore J Iwashyna8, Donald M Yealy9, Catherine L Hough10, Roy G Brower11, Carolyn S Calfee12, Robert C Hyzy8, Michael A Matthay12, Russell R Miller1,2, Jay S Steingrub13, B Taylor Thompson4, Chadwick D Miller14, Terry P Clemmer2,15, Gregory W Hendey16, David T Huang9, Kusum S Mathews17, Nida Qadir16, Mark Tidswell18. 1. 1 Intermountain Medical Center and. 2. 2 University of Utah, Salt Lake City, Utah. 3. 3 Montefiore Healthcare Center, Albert Einstein College of Medicine, Bronx, New York. 4. 4 Massachusetts General Hospital, Harvard University, Boston, Massachusetts. 5. 5 Harvard T. H. Chan School of Public Health, Boston, Massachusetts. 6. 6 Brigham and Women's Hospital, Harvard University, Boston, Massachusetts. 7. 7 Hospital Israelita Albert Einstein, São Paulo, Brazil. 8. 8 University of Michigan, Ann Arbor, Michigan. 9. 9 University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 10. 10 University of Washington, Seattle, Washington. 11. 11 Johns Hopkins University School of Medicine, Baltimore, Maryland. 12. 12 University of California, San Francisco, San Francisco, California. 13. 13 University of Massachusetts Medical School-Baystate, Springfield, Massachusetts. 14. 14 Wake Forest Baptist Health, Winston Salem, North Carolina. 15. 15 LDS Hospital, Salt Lake City, Utah. 16. 16 University of California, Los Angeles, Los Angeles, California. 17. 17 Icahn School of Medicine at Mount Sinai, New York, New York; and. 18. 18 Baystate Medical Center, Springfield, Massachusetts.
Abstract
RATIONALE: 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. OBJECTIVES: We observed patients with acute respiratory failure to assess the feasibility of a pragmatic trial of LTVV and to guide experimental design. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RATIONALE: 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. OBJECTIVES: We observed patients with acute respiratory failure to assess the feasibility of a pragmatic trial of LTVV and to guide experimental design. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Giacomo Bellani; John G Laffey; Tài Pham; Eddy Fan; Laurent Brochard; Andres Esteban; Luciano Gattinoni; Frank van Haren; Anders Larsson; Daniel F McAuley; Marco Ranieri; Gordon Rubenfeld; B Taylor Thompson; Hermann Wrigge; Arthur S Slutsky; Antonio Pesenti Journal: JAMA Date: 2016-02-23 Impact factor: 56.272
Authors: Andrew J Stoltze; Terrence S Wong; Karisa K Harland; Azeemuddin Ahmed; Brian M Fuller; Nicholas M Mohr Journal: J Crit Care Date: 2015-03-03 Impact factor: 3.425
Authors: Roy G Brower; Michael A Matthay; Alan Morris; David Schoenfeld; B Taylor Thompson; Arthur Wheeler Journal: N Engl J Med Date: 2000-05-04 Impact factor: 91.245
Authors: Ravi Kalhan; Mark Mikkelsen; Pali Dedhiya; Jason Christie; Christine Gaughan; Paul N Lanken; Barbara Finkel; Robert Gallop; Barry D Fuchs Journal: Crit Care Med Date: 2006-02 Impact factor: 7.598
Authors: Brian M Fuller; Ian T Ferguson; Nicholas M Mohr; Anne M Drewry; Christopher Palmer; Brian T Wessman; Enyo Ablordeppey; Jacob Keeperman; Robert J Stephens; Cristopher C Briscoe; Angelina A Kolomiets; Richard S Hotchkiss; Marin H Kollef Journal: Ann Emerg Med Date: 2017-03-02 Impact factor: 5.721
Authors: Eric L Eisenstein; Rory Collins; Beena S Cracknell; Oscar Podesta; Elizabeth D Reid; Peter Sandercock; Yuriy Shakhov; Michael L Terrin; Mary Ann Sellers; Robert M Califf; Christopher B Granger; Rafael Diaz Journal: Clin Trials Date: 2008 Impact factor: 2.486
Authors: Fabienne D Simonis; Jan M Binnekade; Annemarije Braber; Harry P Gelissen; Jeroen Heidt; Janneke Horn; Gerard Innemee; Evert de Jonge; Nicole P Juffermans; Peter E Spronk; Lotte M Steuten; Pieter Roel Tuinman; Marijn Vriends; Gwendolyn de Vreede; Rob B de Wilde; Ary Serpa Neto; Marcelo Gama de Abreu; Paolo Pelosi; Marcus J Schultz Journal: Trials Date: 2015-05-24 Impact factor: 2.279
Authors: Tessa L Steel; Sharukh Lokhandwala; Ellen S Caldwell; Nicholas J Johnson; Chadwick D Miller; Michelle N Gong; Catherine L Hough Journal: Acad Emerg Med Date: 2021-04-18 Impact factor: 5.221
Authors: Ken Kuljit S Parhar; Karolina Zjadewicz; Andrea Soo; Alan Sutton; Margaret Zjadewicz; Lauren Doig; Calvin Lam; Andre Ferland; Daniel J Niven; Kirsten M Fiest; Henry T Stelfox; Christopher J Doig Journal: Ann Am Thorac Soc Date: 2019-10
Authors: Kathryn A Artis; Raed A Dweik; Bela Patel; Curtis H Weiss; Kevin C Wilson; Anna R Gagliardi; Sue Huckson; Monika Nothacker; Neill K J Adhikari; Andre Carlos Kajdacsy-Balla Amaral; Ian J Barbash; W Graham Carlos; Deena Kelly Costa; Mark L Metersky; Richard A Mularski; Michael W Sjoding; Carey C Thomson; Robert C Hyzy Journal: Ann Am Thorac Soc Date: 2019-12
Authors: Gregory B Rehm; Irene Cortés-Puch; Brooks T Kuhn; Jimmy Nguyen; Sarina A Fazio; Michael A Johnson; Nicholas R Anderson; Chen-Nee Chuah; Jason Y Adams Journal: Crit Care Explor Date: 2021-01-08
Authors: V Eric Kerchberger; Ryan M Brown; Matthew W Semler; Zhiguo Zhao; Tatsuki Koyama; David R Janz; Julie A Bastarache; Lorraine B Ware Journal: Crit Care Explor Date: 2021-07-06
Authors: Michael J Lanspa; Ithan D Peltan; Jason R Jacobs; Jeffrey S Sorensen; Lori Carpenter; Jeffrey P Ferraro; Samuel M Brown; Jay G Berry; Raj Srivastava; Colin K Grissom Journal: Crit Care Date: 2019-12-27 Impact factor: 19.334