1. Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial
- Author
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Shekhar Ghamande, Bruno Pereira, Christopher J Lindsell, Victor E Ortega, Aaron M Joffe, Heath D White, Muhammad Ali, David R Janz, Kevin M Dischert, Emily Adams, James M Dargin, A M Joffe, Akram Khan, Simanta Dutta, Joanne M Wozniak, Susan Stempek, Olivia F Krol, Brian E Driver, Joseph M Brewer, Stephen P Peters, Rita N Bakhru, Scott Bauer, Christina R Bellinger, Amanda M Brown, Blair Brown, Jerri Brown, Caitlin Bumgarner, Wendy Butcher, Megan Caudle, Arjun B Chatterjee, David J Chodos, Gerardo Corcino, Nathan S Cutler, Travis L Dotson, Daniel C Files, Jonathan L Forbes, Katherine A Gershner, Shannon Ginty, Kiadrick R Hood, April Hazelwood, Katherine Hendricks, Kelly Jacobus, Jonathan T Jaffe, Stacy Kay, Chad A Kloefkorn, Jennifer Krall, Margo T Lannan, Cornelia Lane, Cynthia Lanning, Jessica Lyons, William I Mariencheck, Chad R Marion, Matthew A Maslonka, Sara McClintock, Nathaniel M Meier, Matthew C Miles, Peter J Miller, Sophia Mitchell, Wendy C Moore, Katherine Moss, Andrew M Namen, Dustin L Norton, Stella B Ogake, Jill A Ohar, Jessica A Palakshappa, Rodolfo M Pascual, Sandi Pascual, Aaron Pickens, Adam R Schertz, Matt Strong, Alexander O Sy, Braghadheeswar Thyagarajan, Amy Townsend, Russell Worthen, Michael Wlodarski, Charles Yarbrough, Caroline York, James Dargin, Joanne Wozniak, Christopher Adler, Ahmed Agameya, Michael Colancecco, Daniel Fitelson, Joshua Giaccotto, Gena Han, Louise Kane, Ezra Miller, Timothy Noland, Jaqueline Price, Joseph Plourde, Fraser Mackay, Laura Mahoney, Avignat Patel, Michael Plourde, Zena Saadeh, Sara Shadchehr, Sandeep Somalaraju, Eleanor Summerhill, Ryan Webster, Jordan Winnicki, Ekaterina Yavarovich, D Sheylan, Alejandro C Arroliga, Tasnim Lat, Stephanie Nonas, Milad K Jouzestani, Raya Adi, Chandani Anandkat, Hanae Benchbani, Matthew G Drake, Makrina N Kamel, Ramanpreet Randhawa, and Jessica L Tsui
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Adult ,Resuscitation ,thoracic medicine ,Critical Illness ,medicine.medical_treatment ,Laryngoscopy ,Bolus (medicine) ,Intensive care ,Research Methods ,Intubation, Intratracheal ,Humans ,Multicenter Studies as Topic ,Medicine ,Intubation ,Prospective Studies ,adult intensive & critical care ,Randomized Controlled Trials as Topic ,clinical trials ,medicine.diagnostic_test ,business.industry ,Tracheal intubation ,Shock ,General Medicine ,Institutional review board ,Respiration, Artificial ,Clinical trial ,Anesthesia ,business - Abstract
IntroductionCardiovascular 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 analysisThe 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 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 disseminationThe 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 numberNCT03787732.
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- 2020