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

Autor:	Casey JD; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Janz DR; School of Medicine, Section of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University, New Orleans, Louisiana, USA., Russell DW; Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, USA., Vonderhaar DJ; School of Medicine, Section of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University, New Orleans, Louisiana, USA., Joffe AM; Department of Anesthesiology and Pain Medicinex, University of Washington, Seattle, Washington, USA., Dischert KM; Department of Anesthesiology and Pain Medicinex, University of Washington, Seattle, Washington, USA., Brown RM; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Lester MG; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Zouk AN; Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, USA., Gulati S; Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, USA., Stigler WS; Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, USA., Rice TW; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Semler MW; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2018 Aug 10; Vol. 8 (8), pp. e022139. Date of Electronic Publication: 2018 Aug 10.
DOI:	10.1136/bmjopen-2018-022139
Abstrakt:	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. Competing Interests: 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. (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu