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

doi:10.1513/AnnalsATS.201807-459OC

Observational Study

. 2019 Mar;16(3):356-362.

doi: 10.1513/AnnalsATS.201807-459OC.

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

Michael J Lanspa^{1

2}, Michelle Ng Gong³, David A Schoenfeld^{4

5}, Kathleen Tiffany Lee^{4

5}, Colin K Grissom^{1

2}, Peter C Hou⁶, Ary Serpa-Neto⁷, Samuel M Brown^{1

2}, Theodore J Iwashyna⁸, Donald M Yealy⁹, Catherine L Hough¹⁰, Roy G Brower¹¹, Carolyn S Calfee¹², Robert C Hyzy⁸, Michael A Matthay¹², Russell R Miller 3rd^{1

2}, Jay S Steingrub¹³, B Taylor Thompson⁴, Chadwick D Miller¹⁴, Terry P Clemmer^{2

15}, Gregory W Hendey¹⁶, David T Huang⁹, Kusum S Mathews¹⁷, Nida Qadir¹⁶, Mark Tidswell¹⁸; The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network

Collaborators, Affiliations

Collaborators

The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network:
Douglas Hayden, Richard E Morse, Cathryn F Oldmixon, Nancy J Ringwood, Jay S Steingrub, Leslie De Souza, Cynthia Kardos, Lori Kozikowski, Mark Tidswell, Peter C Hou, Imo P Aisiku, Rebecca M Baron, Laura E Fredenburgh, Zach A Gandee, Anthony F Massaro, A Higuera Moreno, Wei Shao, Raghu R Seethala, Richard R Riker, Adelene Macleaod, Nicholas S Hill, Veronica Bacong, Haval Chweich, John Devlin, Erik Garpestad, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Lihini Keenawinna, Lindsey N Muller, T Pinkhasova, Edwin Bajwa, Michael Filbin, Kathryn A Hibbert, Carrie Holland, Patricia A Arsenault, Pam Sigel, Alan Jones, John R Spurzem, Margaret Cruise, Michael A Matthay, Kathleen D Liu, Annika G Belzer, Carolyn Calfee, Brian M Daniel, Thomas J Deiss, Jeffrey E Gotts, Gregory W Hendey, Zafia Anklesaria, Steven Y Chang, Scott Lewis, Ishan Mehta, Nida Qadir, Jamal Sharif, Joseph Levitt, Rosemary Vojnik, Timothy E Albertson, Jason Y Adams, Maya Juarez, Brian Morrissey, Skyler Pearson, Eyad Almasri, Janna M Blaauw, Adit Ginde, Marc Moss, Lani Finck, Carrie Higgins, Jeffery McKeehan, Eleanor Mills, Amanda Tompkins, Ivor S Douglas, Jason Haukoos, Terra Hiller, Emily Hopkins, Judy L Oaks, Katie Overdier, Meggan Schmidt, David C Van Pelt, Jonathan S Tashkin, James H Finigan, Kenneth Lyn-Kew, Ryan D Paterson, Luciano Lemos-Filho, Pauline K Park, Tina Chen, Sinan Hanna, Kristine Nelson, Bruno DiGiovine, Emanuel P Rivers, Sarah Rubino, Tina Chen, Aluko A Hope, Missiel E Munoz, Swarna Gummadi, Damaris Fuster, Daniel Ceusters, Brenda Lopez, Swarna Gummadi, Lynne D Richardson, Ezra Fass, Neha N Goel, Lisa Richman, Gabriel Schneider, R Duncan Hite, Abhijit Duggal, Andrei Hastings, Thomas E Terndrup, Leesha L Bolton, Matthew C Exline, Emily Robart, Jennifer Frey, Kirk Stiffler, Melissa L. Coury, David Norton, Tammy Roads, Autumn Studer, Derek C Angus, Donald M Yealy, Erin G Gilchrist, David T Huang, Michael L Young, Nancy Campbell, Allison Muller, Susan B Promes, Catherine Hough, Ellen S Caldwell, Sarah C Katsandres, Akram Khan, Steve Haberkorn, Shane D OMahony, Charlene Boisjolie, D Clark Files, Chadwick D Miller, Stephanie B Elliott, Lori S Flores, Justin Doroshenko, Wendell Futrell, Erin Harper, Stacey Phelps, Robert Lockwood, Patrick E Wright, Lea Becker, Kyle B Enfield, Alex Kadl, Mary H Marshall, Mark R Sochor, Marjolein de Wit, Stella Hamman, Colin K Grissom, Todd L Allen, Samuel M Brown, Michael J Lanspa, Valerie Aston, Juhee Peterson, Russell R Miller III, Terry P Clemmer, Stan Pies, Estelle S Harris, Amber Plante, Dixie L Harris, David Nielsen, Wayne E Woodward, Todd W Rice, Wesley H Self, Adrienne H Baughman, Margaret Hayes, Susan Mogan, Matthew W Semler, David R Janz, Paula O Lauto

Affiliations

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.

PMID: 30407869
PMCID: PMC6394119
DOI: 10.1513/AnnalsATS.201807-459OC

Observational Study

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

Michael J Lanspa et al. Ann Am Thorac Soc. 2019 Mar.

. 2019 Mar;16(3):356-362.

doi: 10.1513/AnnalsATS.201807-459OC.

Authors

Collaborators

The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network:
Douglas Hayden, Richard E Morse, Cathryn F Oldmixon, Nancy J Ringwood, Jay S Steingrub, Leslie De Souza, Cynthia Kardos, Lori Kozikowski, Mark Tidswell, Peter C Hou, Imo P Aisiku, Rebecca M Baron, Laura E Fredenburgh, Zach A Gandee, Anthony F Massaro, A Higuera Moreno, Wei Shao, Raghu R Seethala, Richard R Riker, Adelene Macleaod, Nicholas S Hill, Veronica Bacong, Haval Chweich, John Devlin, Erik Garpestad, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Lihini Keenawinna, Lindsey N Muller, T Pinkhasova, Edwin Bajwa, Michael Filbin, Kathryn A Hibbert, Carrie Holland, Patricia A Arsenault, Pam Sigel, Alan Jones, John R Spurzem, Margaret Cruise, Michael A Matthay, Kathleen D Liu, Annika G Belzer, Carolyn Calfee, Brian M Daniel, Thomas J Deiss, Jeffrey E Gotts, Gregory W Hendey, Zafia Anklesaria, Steven Y Chang, Scott Lewis, Ishan Mehta, Nida Qadir, Jamal Sharif, Joseph Levitt, Rosemary Vojnik, Timothy E Albertson, Jason Y Adams, Maya Juarez, Brian Morrissey, Skyler Pearson, Eyad Almasri, Janna M Blaauw, Adit Ginde, Marc Moss, Lani Finck, Carrie Higgins, Jeffery McKeehan, Eleanor Mills, Amanda Tompkins, Ivor S Douglas, Jason Haukoos, Terra Hiller, Emily Hopkins, Judy L Oaks, Katie Overdier, Meggan Schmidt, David C Van Pelt, Jonathan S Tashkin, James H Finigan, Kenneth Lyn-Kew, Ryan D Paterson, Luciano Lemos-Filho, Pauline K Park, Tina Chen, Sinan Hanna, Kristine Nelson, Bruno DiGiovine, Emanuel P Rivers, Sarah Rubino, Tina Chen, Aluko A Hope, Missiel E Munoz, Swarna Gummadi, Damaris Fuster, Daniel Ceusters, Brenda Lopez, Swarna Gummadi, Lynne D Richardson, Ezra Fass, Neha N Goel, Lisa Richman, Gabriel Schneider, R Duncan Hite, Abhijit Duggal, Andrei Hastings, Thomas E Terndrup, Leesha L Bolton, Matthew C Exline, Emily Robart, Jennifer Frey, Kirk Stiffler, Melissa L. Coury, David Norton, Tammy Roads, Autumn Studer, Derek C Angus, Donald M Yealy, Erin G Gilchrist, David T Huang, Michael L Young, Nancy Campbell, Allison Muller, Susan B Promes, Catherine Hough, Ellen S Caldwell, Sarah C Katsandres, Akram Khan, Steve Haberkorn, Shane D OMahony, Charlene Boisjolie, D Clark Files, Chadwick D Miller, Stephanie B Elliott, Lori S Flores, Justin Doroshenko, Wendell Futrell, Erin Harper, Stacey Phelps, Robert Lockwood, Patrick E Wright, Lea Becker, Kyle B Enfield, Alex Kadl, Mary H Marshall, Mark R Sochor, Marjolein de Wit, Stella Hamman, Colin K Grissom, Todd L Allen, Samuel M Brown, Michael J Lanspa, Valerie Aston, Juhee Peterson, Russell R Miller III, Terry P Clemmer, Stan Pies, Estelle S Harris, Amber Plante, Dixie L Harris, David Nielsen, Wayne E Woodward, Todd W Rice, Wesley H Self, Adrienne H Baughman, Margaret Hayes, Susan Mogan, Matthew W Semler, David R Janz, Paula O Lauto

Affiliations

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.

PMID: 30407869
PMCID: PMC6394119
DOI: 10.1513/AnnalsATS.201807-459OC

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.

Keywords: acute respiratory distress syndrome; low-stretch ventilation; low–tidal volume ventilation; lung-protective ventilation; mechanical ventilation.

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Figures

**Figure 1.**
Estimated mortality benefit detectable in a stepped-wedged cluster-randomized controlled trial of low–tidal volume ventilation as sites with highest adherence to low–tidal volume ventilation less than or equal to 6.5 ml/kg predicted body weight are excluded from the trial.

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To Enjoy the FRUIT of Your Labors, Don't Forget to Look before You Leap!
Fan E, Rowan KM. Fan E, et al. Ann Am Thorac Soc. 2019 Mar;16(3):309-310. doi: 10.1513/AnnalsATS.201811-814ED. Ann Am Thorac Soc. 2019. PMID: 30821490 No abstract available.

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Peltan ID, Knighton AJ, Barney BJ, Wolfe D, Jacobs JR, Klippel C, Allen L, Lanspa MJ, Leither LM, Brown SM, Srivastava R, Grissom CK. Peltan ID, et al. Ann Am Thorac Soc. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC. Ann Am Thorac Soc. 2023. PMID: 36350983 Free PMC article. Clinical Trial.
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References

1. Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000;342:1301–1308. - PubMed
1. Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, et al. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006;34:300–306. - PubMed
1. Spece LJ, Caldwell ES, Gundel SA, Hough CL. Factors associated with underuse of lung protective ventilation for ARDS [abstract] Am J Respir Crit Care Med. 2015;191:A3105.
1. Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, et al. LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016;42:1865–1876. - PubMed
1. Allison MG, Scott MC, Hu KM, Witting MD, Winters ME. High initial tidal volumes in emergency department patients at risk for acute respiratory distress syndrome. J Crit Care. 2015;30:341–343. - PubMed

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[1] Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000;342:1301–1308. - PubMed

[2] Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000;342:1301–1308. - PubMed

[3] Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, et al. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006;34:300–306. - PubMed

[4] Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, et al. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006;34:300–306. - PubMed

[5] Spece LJ, Caldwell ES, Gundel SA, Hough CL. Factors associated with underuse of lung protective ventilation for ARDS [abstract] Am J Respir Crit Care Med. 2015;191:A3105.

[6] Spece LJ, Caldwell ES, Gundel SA, Hough CL. Factors associated with underuse of lung protective ventilation for ARDS [abstract] Am J Respir Crit Care Med. 2015;191:A3105.

[7] Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, et al. LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016;42:1865–1876. - PubMed

[8] Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, et al. LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016;42:1865–1876. - PubMed

[9] Allison MG, Scott MC, Hu KM, Witting MD, Winters ME. High initial tidal volumes in emergency department patients at risk for acute respiratory distress syndrome. J Crit Care. 2015;30:341–343. - PubMed

[10] Allison MG, Scott MC, Hu KM, Witting MD, Winters ME. High initial tidal volumes in emergency department patients at risk for acute respiratory distress syndrome. J Crit Care. 2015;30:341–343. - PubMed

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

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

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