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Crit Care Med. 2015 Oct;43(10):2076-84. doi: 10.1097/CCM.0000000000001157.

Protocols and Hospital Mortality in Critically Ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.

Collaborators (156)

O'Keeffe T, Collins C, Liebler J, Ahoui A, Nersiseyan A, Shah U, Shigemitsu H, Thaiyananthan N, Hsu J, Ho L, Barr J, Kaufman D, Siner JM, Siegel MD, Martin GS, Coopersmith C, Fisher M, Gutteridge D, Brown M, Lee S, Smith A, Martin GS, Leeper K, Brown M, Martin GS, Cribbs S, Esper A, Brown M, Gutteridge D, Dosunmu O, Hassan Z, Liu J, Ridder B, Atkinson M, Draftz A, Durgin J, Rikhman Y, Scheckel J, Walthers M, Luger G, Downer C, Sadikot RT, Javaid K, Rodgers D, Sharma V, Sevransky J, Checkley W, Geocadin R, Murphy DJ, Needham D, Sapirstein A, Schwartz S, Whitman G, Winters B, Workneh A, Zakaria S, Martinez A, Keith F, Johnson S, Herr D, Netzer G, Shanholtz C, Sampaio A, Titus J, Eberlein M, Rotello L, Anderson J, Shahul S, Banner-Goodspeed V, Howell M, Hunziker S, Nielsen V, Stevens J, Talmor D, Patil N, Chin L, Myers M, Ryan S, Bander J, Park PK, Blum JM, Arora V, Brierley K, DeVito J, Harris J, Jewell E, Rohner D, To KB, Dickinson S, Pickering BW, Giru J, Kashyap R, Trivedi N, Dwyer T, Brownback K, Chang S, Cohen Z, Italiano F, Kahn Z, Patrawalla A, Gonzales D, Campbell P, Chong D, Baldwin M, Benvenuto L, Yip N, Pastores SM, Pietropaoli A, Falkner K, Bouck T, Mattingly AM, Morris PE, Flores LS, Butt A, Mazer M, Jernigan K, Wright P, Groce S, McLean J, Overton A, Guzman JA, El Fadl MA, Frederick T, Cumbo-Nacheli G, Komara J, O'Brien JM, Ali N, Exline M, Hoag J, Albu D, McLaughlin P, Hoag J, Abramian E, Zeibeq J, Prasad M, Zuick S, Fremont RD, Emuwa CO, Nwazue VC, Owolabi OS, Cotton B, Hart G, Jenkins J, Rice TW, Girard TD, Hays M, Mogan S, Aisiku IP, Brown S, Grissom C, Miller R 3rd, Austin A, Gallo H, Kumar N, Putman M, Ondrush J.

Author information

1Division of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, GA. 2Division of Pulmonary and Critical Care, Johns Hopkins University, Baltimore, MD. 3Department of Anesthesia, Mayo Clinic, Rochester, MN. 4Department of Anesthesiology, Stanford University, Palo Alto, CA. 5Division of Pulmonary and Critical Care, Intermountain Medical Center and University of Utah, Salt Lake City, UT. 6Division of Pulmonary and Critical Care, UCLA, Los Angeles, CA. 7Division of Pulmonary and Critical Care Medicine, Columbia University Medical Center, New York, NY. 8Section of Pulmonary and Critical Care Medicine, Yale University School of Medicine, New Haven, CT. 9Division of Pulmonary and Critical Care, Meharry Medical College, Nashville, TN. 10Division of Allergy, Pulmonary, and Critical Care Medicine and Center for Health Services Research at the, Vanderbilt University School of Medicine, Nashville, TN. 11Division of Pulmonary and Critical Care, Drexel University, Philadelphia, PA. 12Department of Surgical Critical Care, University of Maryland, Baltimore, MD. 13Division of Pulmonary, Allergy, and Critical Care, University of Pennsylvania, Philadelphia, PA. 14Division of Pulmonary Critical Care and Sleep Medicine, University of Southern California, Los Angeles, CA. 15Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Ohio State University, Columbus, OH. 16Department of Surgery, University of Arizona, Tucson, AZ. 17Division of Acute Care Surgery, Department of Surgery, University of Michigan Health System, Ann Arbor, MI. 18Department of Anesthesiology and Critical Care Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY. 19Department of Surgery, Division of Thoracic Surgery, Division of Trauma, Burn & Critical Care, Brigham and Women's Hospital, Boston, MA. 20Division of Pulmonary and Critical Care Medicine, University of Rochester, Rochester, NY. 21INOVA Fairfax Hospital, Falls Church, VA. 22Suburban Hospital, Bethesda, MD. 23Department of A



Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs.


Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week.


A total of 6,179 critically ill patients.


Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.




The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15-21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27).


Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.

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