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Emergency medicine
Protocol
Protocol for a prospective, observational cohort study of awareness in mechanically ventilated patients admitted from the emergency department: the ED-AWARENESS study
  1. Ryan D Pappal1,
  2. Brian W Roberts2,
  3. Nicholas M Mohr3,
  4. Enyo Ablordeppey4,
  5. Brian T Wessman4,
  6. Anne M Drewry5,
  7. Yan Yan6,7,
  8. Marin H Kollef8,
  9. Michael Simon Avidan5,
  10. Brian M Fuller4
  1. 1 Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA
  2. 2 Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  3. 3 Emergency Medicine and Anesthesiology, Roy J. and Lucille A. Carver College of Medicine University of Iowa, Iowa City, Iowa, USA
  4. 4 Anesthesiology and Emergency Medicine, Washington University, Saint Louis, Missouri, USA
  5. 5 Anesthesiology, Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA
  6. 6 Clinical Epidemiology Center, VA Saint Louis Health Care System, Saint Louis, Missouri, USA
  7. 7 Public Health Sciences, Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA
  8. 8 Medicine, Washington University in Saint Louis School of Medicine, Saint Louis, Missouri, USA
  1. Correspondence to Dr Brian M Fuller; fullerb{at}wusm.wustl.edu

Abstract

Introduction Awareness with paralysis is a complication with potentially devastating psychological consequences for mechanically ventilated patients. While rigorous investigation into awareness has occurred for operating room patients, little attention has been paid outside of this domain. Mechanically ventilated patients in the emergency department (ED) have been historically managed in a way that predisposes them to awareness events: high incidence of neuromuscular blockade use, underdosing of analgesia and sedation, delayed administration of analgesia and sedation after intubation, and a lack of monitoring of sedation targets and depth. These practice patterns are discordant to recommendations for reducing the incidence of awareness, suggesting there is significant rationale to examine awareness in the ED population.

Methods and analysis This is a single centre, prospective cohort study examining the incidence of awareness in mechanically ventilated ED patients. A cohort of 383 mechanically ventilated ED patients will be included. The primary outcome is awareness with paralysis. Qualitative reports of all awareness events will be provided. Recognising the potential problem with conventional multivariable analysis arising from a small number of events (expected less than 10—phenomenon of separation), Firth penalised method, exact logistic regression model or penalised maximum likelihood estimation shrinkage (Ridge, LASSO) will be used to assess for predictors of awareness.

Ethics and dissemination Approval of the study by the Human Research Protection Office has been obtained. This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.

  • awareness
  • memories
  • mechanical ventilation
  • emergency medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-033379

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    Footnotes

    • Contributors BMF: conception and study design, acquisition of data, analysis and interpretation of data, drafting and revising the manuscript. RDP: conception and study design, acquisition of data, analysis and interpretation of data, and revising the manuscript. BWR: study design, analysis and interpretation of data, drafting and revising the manuscript. NMM: study design, analysis and interpretation of data, drafting and revising the manuscript. AMD: study design, analysis and interpretation of data, drafting and revising the manuscript. EA: study design, analysis and interpretation of data, drafting and revising the manuscript. BTW: study design, analysis and interpretation of data, drafting and revising the manuscript. YY: study design, analysis and interpretation of data, drafting and revising the manuscript. MHK: study design, analysis and interpretation of data, drafting and revising the manuscript. MSA: study design, analysis and interpretation of data, drafting and revising the manuscript. All authors have read and given final approval of the submitted manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol has received ethical approval by the Human Research Protection Office at Washington University School of Medicine in St. Louis, and will be conducted with waiver of informed consent.

    • Provenance and peer review Not commissioned; externally peer reviewed.