Article Text
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.
- adult anaesthesia
- adult thoracic medicine
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Footnotes
Contributors Study concept and design: JDC, MWS, DRJ and TWR; acquisition of data: JDC, DRJ, DWR, DJV, AMJ, KMD, RMB, MGL, ANZ, SG, WSS and MWS; analysis and interpretation of data, drafting of the manuscript and statistical analysis: JDC and MWS; critical revision of the manuscript for important intellectual content: JDC, RMB and MWS; study supervision: TWR.
Funding JDC was supported in part by the NIH (2T32HL087738-12). MWS was supported in part by the NHLBI (HL087738-09 and K12HL133117). DWR was supported in part by the NIH/NHLBI (T32HL105346-07). TWR was supported in part by the NIH (R34HL105869). Data collection used the Research Electronic Data Capture (REDCap) tool developed and maintained with Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH).
Disclaimer The funding institutions had no role in (1) conception, design or conduct of the study, (2) collection, management, analysis, interpretation or presentation of the data or (3) preparation, review or approval of the manuscript.
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.
Patient consent Not required.
Ethics approval Institutional Review Board of Vanderbilt University Medical Center.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement This manuscript details the protocol and statistical analysis plan for an ongoing clinical trial. At present there are no data available for sharing.