BMJ Open (Sep 2020)
Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial
- ,
- Li Wang,
- Tamer Hudali,
- Shekhar Ghamande,
- Megan Moore,
- Bruno Pereira,
- Christopher J Lindsell,
- Wesley H Self,
- Todd W Rice,
- Matthew W Semler,
- Kate O’Connor,
- David B Page,
- Victor E Ortega,
- Aaron M Joffe,
- Swati Gulati,
- G Patel,
- Heath D White,
- Muhammad Ali,
- Jonathan D Casey,
- David R Janz,
- Derek W Russell,
- Derek J Vonderhaar,
- Kevin M Dischert,
- William S Stigler,
- Emily Adams,
- Kevin W Gibbs,
- James M Dargin,
- A M Joffe,
- Akram Khan,
- Simanta Dutta,
- Janna S Landsperger,
- Sarah W Robison,
- Itay Bentov,
- Joanne M Wozniak,
- Susan Stempek,
- Olivia F Krol,
- Matthew E Prekker,
- Brian E Driver,
- Joseph M Brewer,
- Christopher John Lindsell,
- David Janz,
- 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,
- John P Gaillard,
- 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,
- Bradley Lloyd,
- 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,
- Sheetal Gandotra,
- Anna Altz-Stamm,
- Cristina Bardita,
- Mary Clay Boone,
- Joe W Chiles,
- Kristina Collins,
- Abby Drescher,
- Kevin G Dsouza,
- Janna Dunn,
- Stacy Ejem,
- Josh Gautney,
- Nicole Harris,
- Savannah Herder,
- R Chad Wade,
- Rutwij Joshi,
- Daniel Kelmenson,
- Anne Merrill Mason,
- Scott R Merriman,
- Takudzwa Mkorombindo,
- Jada Nowak,
- D Sheylan,
- Lisa Sarratt,
- Tabitha Stewart,
- Kadambari Vijaykumar,
- Gina White,
- Micah R Whitson,
- Christopher Barnes,
- Andrew M Walters,
- Alejandro C Arroliga,
- Tasnim Lat,
- Stephanie Nonas,
- Milad K Jouzestani,
- Raya Adi,
- Chandani Anandkat,
- Hanae Benchbani,
- Matthew G Drake,
- Makrina N Kamel,
- Ramanpreet Randhawa,
- Jessica L Tsui
Affiliations
- GENYO, Pfizer-University, Granada, Spain, Granada, Spain
- Li Wang
- 8Cleveland Clinic and Lerner College of Medicine, Cleveland, OH, USA
- Tamer Hudali
- Shekhar Ghamande
- Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA
- Megan Moore
- Injury Prevention and Research Center, Harborview Medical Center, Seattle, Washington, USA
- Bruno Pereira
- Clinical Research and Innovation Direction, University Hospital of Clermont Ferrand, Clermont-Ferrand, France, Clermont-Ferrand, France
- Christopher J Lindsell
- 5 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
- Wesley H Self
- Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
- Todd W Rice
- professor of medicine
- Matthew W Semler
- Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
- Kate O’Connor
- David B Page
- Earle A Chiles Research Institute, Portland, Oregon, USA
- Victor E Ortega
- Internal Medicine, Wake Forest Health Sciences, Winston-Salem, North Carolina, USA
- Aaron M Joffe
- Department of Anesthesiology and Pain Medicine, Harborview Medical Center, Seattle, Washington, USA
- Swati Gulati
- 3 Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Womens Hospital, Boston, Massachusetts, USA
- G Patel
- Barking, Havering and Redbridge University Hospitals NHS Trust, London, UK
- Heath D White
- Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA
- Muhammad Ali
- Wilmer Eye Institute, Johns Hopkins Wilmer Eye Institute, Baltimore, Maryland, USA
- Jonathan D Casey
- Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
- David R Janz
- 4 Department of Medicine, Section of Pulmonary/Critical Care and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA
- Derek W Russell
- Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA
- Derek J Vonderhaar
- Department of Pulmonary/Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA
- Kevin M Dischert
- William S Stigler
- Emily Adams
- medical student
- Kevin W Gibbs
- Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA
- James M Dargin
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA
- A M Joffe
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA
- Akram Khan
- 4 Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA
- Simanta Dutta
- Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA
- Janna S Landsperger
- Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
- Sarah W Robison
- Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
- Itay Bentov
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA
- Joanne M Wozniak
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA
- Susan Stempek
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA
- Olivia F Krol
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA
- Matthew E Prekker
- Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA
- Brian E Driver
- Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA
- Joseph M Brewer
- Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA
- Christopher John Lindsell
- Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
- David Janz
- Section of Pulmonary/Critical Care Medicine & Allergy/Immunology, Louisiana State University, New Orleans, Louisiana, USA
- 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
- John P Gaillard
- Department of Emergency Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA
- 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
- Bradley Lloyd
- 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
- Sheetal Gandotra
- Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA
- Anna Altz-Stamm
- Cristina Bardita
- Mary Clay Boone
- Joe W Chiles
- Kristina Collins
- Abby Drescher
- Kevin G Dsouza
- Janna Dunn
- Stacy Ejem
- Josh Gautney
- Nicole Harris
- Savannah Herder
- R Chad Wade
- Rutwij Joshi
- Daniel Kelmenson
- Anne Merrill Mason
- Scott R Merriman
- Takudzwa Mkorombindo
- Jada Nowak
- D Sheylan
- Lisa Sarratt
- Tabitha Stewart
- Kadambari Vijaykumar
- Gina White
- Micah R Whitson
- Department of Emergency Medicine, The University of Alabama at Birmingham, Birmingham, Alabama, USA
- Christopher Barnes
- Andrew M Walters
- Alejandro C Arroliga
- Tasnim Lat
- Stephanie Nonas
- Milad K Jouzestani
- Raya Adi
- Chandani Anandkat
- Hanae Benchbani
- Matthew G Drake
- Makrina N Kamel
- Ramanpreet Randhawa
- Jessica L Tsui
- DOI
- https://doi.org/10.1136/bmjopen-2019-036671
- Journal volume & issue
-
Vol. 10,
no. 9
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 χ2 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.
