. 2020 Sep 18;10(9):e036671.

doi: 10.1136/bmjopen-2019-036671.

Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial

Derek W Russell^#^{1

2}, Jonathan D Casey^#³, Kevin W Gibbs⁴, James M Dargin⁵, Derek J Vonderhaar⁶, A M Joffe⁷, Shekhar Ghamande⁸, Akram Khan⁹, Simanta Dutta⁴, Janna S Landsperger³, Sarah W Robison¹⁰, Itay Bentov⁷, Joanne M Wozniak⁵, Susan Stempek⁵, Heath D White⁸, Olivia F Krol⁹, Matthew E Prekker^{11

12}, Brian E Driver¹¹, Joseph M Brewer¹³, Li Wang³, Christopher John Lindsell³, Wesley H Self¹⁴, Todd W Rice³, Matthew W Semler^#³, David Janz^#¹⁵; PREPARE II Investigators

Collaborators, Affiliations

Collaborators

PREPARE II Investigators:
Kevin W Gibbs, Simanta Dutta, Stephen P Peters, Muhammad Ali, 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, Victor E Ortega, 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, Jonathan D Casey, Janna S Landsperger, Li Wang, Todd W Rice, Matthew W Semler, Wesley H Self, Bradley Lloyd, James Dargin, Joanne Wozniak, Susan Stempek, Christopher Adler, Ahmed Agameya, Michael Colancecco, Daniel Fitelson, Joshua Giaccotto, Gena Han, Louise Kane, Ezra Miller, Timothy Noland, Jaqueline Price, Joseph Plourde, Emily Adams, Fraser Mackay, Laura Mahoney, Avignat Patel, Michael Plourde, Zena Saadeh, Sara Shadchehr, Sandeep Somalaraju, Eleanor Summerhill, Ryan Webster, Jordan Winnicki, Ekaterina Yavarovich, Derek W Russell, Sarah W Robison, Sheetal Gandotra, Swati Gulati, 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, Tamer Hudali, R Chad Wade, Rutwij Joshi, Daniel Kelmenson, Anne Merrill Mason, Scott R Merriman, Takudzwa Mkorombindo, Megan Moore, Jada Nowak, Kate O'Connor, David B Page, D Sheylan, G Patel, Bruno Pereira, Lisa Sarratt, Tabitha Stewart, William S Stigler, Kadambari Vijaykumar, Gina White, Micah R Whitson, Derek J Vonderhaar, Kevin M Dischert, Aaron M Joffe, Itay Bentov, Christopher Barnes, Andrew M Walters, Shekhar Ghamande, Heath D White, Alejandro C Arroliga, Tasnim Lat, Akram Khan, Olivia F Krol, Stephanie Nonas, Milad K Jouzestani, Raya Adi, Chandani Anandkat, Hanae Benchbani, Matthew G Drake, Makrina N Kamel, Ramanpreet Randhawa, Jessica L Tsui, Matthew E Prekker, Brian E Driver, Joseph M Brewer, David R Janz, Christopher J Lindsell

Affiliations

¹ Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.
² Veterans Integrated Service Network 7, Department of Veterans Affairs, Washington, District of Columbia, USA.
³ Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
⁴ Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁵ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
⁶ Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.
⁷ Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
⁸ Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.
⁹ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.
¹⁰ Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
¹¹ Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
¹² Department of Medicine, Division of Pulmonary/Critical Care Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
¹³ Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.
¹⁴ Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
¹⁵ Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.

^# Contributed equally.

PMID: 32948554
PMCID: PMC7511643
DOI: 10.1136/bmjopen-2019-036671

Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial

Derek W Russell et al. BMJ Open. 2020.

. 2020 Sep 18;10(9):e036671.

doi: 10.1136/bmjopen-2019-036671.

Authors

Collaborators

PREPARE II Investigators:
Kevin W Gibbs, Simanta Dutta, Stephen P Peters, Muhammad Ali, 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, Victor E Ortega, 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, Jonathan D Casey, Janna S Landsperger, Li Wang, Todd W Rice, Matthew W Semler, Wesley H Self, Bradley Lloyd, James Dargin, Joanne Wozniak, Susan Stempek, Christopher Adler, Ahmed Agameya, Michael Colancecco, Daniel Fitelson, Joshua Giaccotto, Gena Han, Louise Kane, Ezra Miller, Timothy Noland, Jaqueline Price, Joseph Plourde, Emily Adams, Fraser Mackay, Laura Mahoney, Avignat Patel, Michael Plourde, Zena Saadeh, Sara Shadchehr, Sandeep Somalaraju, Eleanor Summerhill, Ryan Webster, Jordan Winnicki, Ekaterina Yavarovich, Derek W Russell, Sarah W Robison, Sheetal Gandotra, Swati Gulati, 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, Tamer Hudali, R Chad Wade, Rutwij Joshi, Daniel Kelmenson, Anne Merrill Mason, Scott R Merriman, Takudzwa Mkorombindo, Megan Moore, Jada Nowak, Kate O'Connor, David B Page, D Sheylan, G Patel, Bruno Pereira, Lisa Sarratt, Tabitha Stewart, William S Stigler, Kadambari Vijaykumar, Gina White, Micah R Whitson, Derek J Vonderhaar, Kevin M Dischert, Aaron M Joffe, Itay Bentov, Christopher Barnes, Andrew M Walters, Shekhar Ghamande, Heath D White, Alejandro C Arroliga, Tasnim Lat, Akram Khan, Olivia F Krol, Stephanie Nonas, Milad K Jouzestani, Raya Adi, Chandani Anandkat, Hanae Benchbani, Matthew G Drake, Makrina N Kamel, Ramanpreet Randhawa, Jessica L Tsui, Matthew E Prekker, Brian E Driver, Joseph M Brewer, David R Janz, Christopher J Lindsell

Affiliations

¹ Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.
² Veterans Integrated Service Network 7, Department of Veterans Affairs, Washington, District of Columbia, USA.
³ Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
⁴ Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁵ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.
⁶ Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.
⁷ Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.
⁸ Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.
⁹ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.
¹⁰ Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
¹¹ Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
¹² Department of Medicine, Division of Pulmonary/Critical Care Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
¹³ Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.
¹⁴ Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
¹⁵ Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.

^# Contributed equally.

PMID: 32948554
PMCID: PMC7511643
DOI: 10.1136/bmjopen-2019-036671

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.

Keywords: adult intensive & critical care; clinical trials; thoracic medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Timeline of tracheal intubation (TI), enrolment, study interventions and primary/secondary outcome eligibility in an enrolled patient.

See this image and copyright information in PMC

References

1. Simpson GD, Ross MJ, McKeown DW, et al. . Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth 2012;108:792–9. 10.1093/bja/aer504 - DOI - PubMed
1. Martin LD, Mhyre JM, Shanks AM, et al. . 3,423 emergency tracheal Intubations at a university hospital: airway outcomes and complications. Anesthesiology 2011;114:42–8. 10.1097/ALN.0b013e318201c415 - DOI - PubMed
1. Leibowitz AB. Tracheal intubation in the intensive care unit: extremely hazardous even in the best of hands. Crit Care Med 2006;34:2497–8. 10.1097/01.CCM.0000235993.47514.8F - DOI - PubMed
1. Jaber S, Jung B, Corne P, et al. . An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med 2010;36:248–55. 10.1007/s00134-009-1717-8 - DOI - PubMed
1. Green RS, Turgeon AF, McIntyre LA, et al. . Postintubation hypotension in intensive care unit patients: a multicenter cohort study. J Crit Care 2015;30:1055–60. 10.1016/j.jcrc.2015.06.007 - DOI - PubMed

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Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial

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Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial

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Conflict of interest statement

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