Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Aug 10;8(8):e022139.
doi: 10.1136/bmjopen-2018-022139.

Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial

Jonathan D Casey  1 , David R Janz  2 , Derek W Russell  3 , Derek J Vonderhaar  2 , Aaron M Joffe  4 , Kevin M Dischert  4 , Ryan M Brown  1 , Michael G Lester  1 , Aline N Zouk  3 , Swati Gulati  3 , William S Stigler  3 , Todd W Rice  1 , Matthew W Semler  1 ; PreVent Investigators and the Pragmatic Critical Care Research Group
Affiliations
Randomized Controlled Trial

Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial

Jonathan D Casey et al. BMJ Open. .

Abstract

Introduction: Hypoxaemia is the most common complication during endotracheal intubation of critically ill adults, and it increases the risk of cardiac arrest and death. Manual ventilation between induction and intubation has been hypothesised to decrease the incidence of hypoxaemia, but efficacy and safety data are lacking.

Methods and analysis: The Preventing Hypoxemia with Manual Ventilation during Endotracheal Intubation trial is a prospective, multicentre, non-blinded randomised clinical trial being conducted in seven intensive care units in the USA. A total of 400 critically ill adults undergoing endotracheal intubation will be randomised 1:1 to receive prophylactic manual ventilation between induction and endotracheal intubation using a bag-valve-mask device or no prophylactic ventilation. The primary outcome is the lowest arterial oxygen saturation between induction and 2 min after successful endotracheal intubation, which will be analysed as an unadjusted, intention-to-treat comparison of patients randomised to prophylactic ventilation versus patients randomised to no prophylactic ventilation. The secondary outcome is the incidence of severe hypoxaemia, defined as any arterial oxygen saturation of less than 80% between induction and 2 min after endotracheal intubation. Enrolment began on 2 February 2017 and is expected to be complete in May 2018.

Ethics and dissemination: The trial was approved by the institutional review boards or designees of all participating centres. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration number: NCT03026322; Pre-results.

Keywords: adult anaesthesia; adult thoracic medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors declared no potential conflicts of interest with the current work. TWR reported serving on an advisory board for Avisa Pharma, LLC, and as the Director of Medical Affairs for Cumberland Pharmaceuticals.

Figures

Figure 1
Figure 1
Phases of rapid sequence intubation without prophylactic manual ventilation. NMB, neuromuscular blockade; RSI, rapid sequence intubation.
Figure 2
Figure 2
Phases of rapid sequence intubation with prophylactic manual ventilation. NMB, neuromuscular blockade; RSI, rapid sequence intubation.
Figure 3
Figure 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Enrolment, interventions and assessments. Baseline variables obtained from electronic medical record include: demographic characteristics, indication for intubation, history of pulmonary disease, severity of illness at enrolment, risk factors for aspiration, non-invasive ventilator use and highest fraction of inspired oxygen in the 6 hours prior to intubation. Periprocedural variables, including oxygen saturation at induction, lowest arterial oxygen saturation between induction and 2 min following endotracheal intubation and time to intubation will be collected by a trained, independent observer, not affiliated with the performance of the procedure. Clinical outcomes include: vital status, number of ventilator-free days to 28 days, and number of intensive care unit-free days to 28 days. ETI, endotracheal intubation; NMB, neuromuscular blockade.
See this image and copyright information in PMC

References

    1. Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology 1995;82:367–76. - PubMed
    1. Simpson GD, Ross MJ, McKeown DW, et al. . Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth 2012;108:792–9. 10.1093/bja/aer504 - DOI - PubMed
    1. Leibowitz AB. Tracheal intubation in the intensive care unit: extremely hazardous even in the best of hands. Crit Care Med 2006;34:2497–8. 10.1097/01.CCM.0000235993.47514.8F - DOI - PubMed
    1. Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth 2004;16:508–16. 10.1016/j.jclinane.2004.01.007 - DOI - PubMed
    1. Martin LD, Mhyre JM, Shanks AM, et al. . 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology 2011;114:42–8. 10.1097/ALN.0b013e318201c415 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources