Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial
Year: 2020
Type: article
Study design: Study Protocol
Abstract: Introduction Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation. Methods and analysis The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2 test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020. Ethics and dissemination The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. Trial registration number NCT03787732 .
Source: BMJ Open
Authors: Derek W Russell, Jonathan D Casey, Kevin W Gibbs, James M Dargin, Derek J Vonderhaar, A M Joffe, Shekhar Ghamande, Akram Khan, Simanta Dutta, Janna S Landsperger, Sarah W Robison, Itay Bentov, Joanne M Wozniak, Susan Stempek, Heath D White, Olivia F Krol, Matthew E Prekker, Brian E Driver, Joseph M Brewer, Li Wang, Christopher John Lindsell, Wesley H Self, Todd W Rice, Matthew W Semler, David Janz
Institutions: United States Department of Veterans Affairs, Veterans Health Administration, University of Alabama at Birmingham, UAB Medicine, Vanderbilt University, Atrium Health Wake Forest Baptist, Wake Forest University Health Sciences, Wake Forest University, Lahey Hospital and Medical Center, Lahey Medical Center, Ochsner Health System, University of Washington, Baylor Scott & White Medical Center - Temple, Oregon Health & Science University, Hennepin County Medical Center, University of Mississippi Medical Center, Louisiana State University, Louisiana State University Health Sciences Center New Orleans
Language: English
Subfield: Anesthesiology and Pain Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Awards: The Vanderbilt Emergency Care Research Training Program, Bag-Mask Ventilation to PreVent Hypoxemia during Tracheal Intubation in the Emergency Department: A Clinical Trial, Oxygen Saturation Targets during Mechanical Ventilation of Critically Ill Adults: A Clinical Trial, Activated Neutrophilic Exosome as Biomarker and Therapeutic Target in COPD, G8928743685, Clinical and Translational Training Program in Pulmonary Medicine
OpenAlex ID: W3087622247