Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial

Janz, David R.; Vonderhaar, Derek J; Hoffman, Ross; Turlapati, Naveen; Samant, Sneha D.; Clark, Page; Krishnan, A.; Gresens, Joseph; Hill, Cody; Matthew, Bobby; Henry, J.C.C.; Miller, Jason D.; Paccione, Rose; Majid-Moosa, Abdulla; Santanilla, Jairo I.; Semler, Matthew W.; Rice, Todd W.; Casey, Jonathan D; Heideman, Brent E.; Wilfong, Erin M.; Hewlett, Justin C; Halliday, Stephen; Kerchberger, V.E.; Brown, Ryan M; Huerta, Luis E.; Merrick, Christopher; Atwater, Thomas; Kocurek, Emily G.; McKown, Andrew C.; Winters, Nichelle I.; Habegger, L.; Mart, Matthew F.; Berg, Jeannette Zinggeler; Noblit, Christina C; Flemmons, Lisa N; Dischert, Kevin M; Joffe, Aaron M.; Bentov, Itay; Archibald, Trefan; Arenas, Alejandro; Baldridge, Camelia; Bansal, Gaurav; Barnes, Christopher; Bishop, Nicholas; Bryce, Beth; Byrne, Laura; Clement, Rachel; DeLaCruz, Carla; Deshpande, Priya; Gong, Zi; Green, John; Austin, Henry; Herstein, Andrew; Huang, Jessica J M; Heier, Jake; Jenson, Bonnie; Johnston, Lynn; Langeland, Cara; Lee, Calvin; Nowlin, Alex; Reece‐Nguyen, Travis; Schultz, Hunter; Segal, Graeme; Slade, Ian R.; Solomon, Stuart; Stehpey, Sarah; Thompson, R.; Trausch, David; Welker, Carson C.; Zhang, Raymond; Russell, Derek W.; Zouk, Aline N.; Gulati, Swati; Stigler, William S.; Fain, Jason; Garcia, Bryan; LaFon, David C.; He, Chao; O’Connor, James V.; Campbell, David L.; Powner, Jordan; McElwee, Samuel; Bardita, Cristina; Dsouza, K.G.; Pereira, Glauber B.; Robinson, Sarah L.; Blumhof, Scott; Dargin, James; Stempek, Susan; Wozniak, Joanne; Pataramekin, Piyanuch; Desai, Dhruv; Yayarovich, Ekaterina; DeMatteo, Robert; Somalaraiu, Sandeep; Adler, Christopher; Reid, Courtney; Plourde, Michael; Winnicki, Jordan; Noland, Timothy; Geva, Tamar; Gazourian, Lee; Patel, Avignat S.; Eissa, Khaled; Giacotto, Joshua; Fitelson, Daniel; Colancecco, Michael; Gray, Anthony W.; West, Jason R.; Caputo, Nicholas D.; Ryan, Mary; Parry, Thomas M.; Azan, Benjamin; Khairat, Ali; Morton, Renee; Lewandowski, David; Vaca, Carlos

doi:10.1016/s2213-2600(19)30246-2

Cited by 91 publications

(52 citation statements)

References 33 publications

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“…However, the only reported trial to examine administration of a pre-intubation fluid bolus, the PrePARE (Preventing cardiovascular collaPse with Administration of fluid Resuscitation before Endotracheal intubation) trial, reported that a pre-intubation fluid bolus had no effect on the overall rate of cardiovascular collapse. 8 The receipt of positive pressure ventilation, however, appeared to modify the effect of a fluid bolus administration on cardiovascular collapse in the PrePARE trial. Patients receiving positive pressure ventilation appeared to have a lower rate cardiovascular collapse in the fluid bolus group compared with the no fluid bolus group, both among patients receiving non-invasive ventilation for pre-oxygenation (RR 0.51; 95% CI 0.24 to 1.09; p value for interaction =0.032) and among patients receiving bag-mask ventilation between induction and laryngoscopy (RR 0.61; 95% CI 0.33 to 1.13; p value for interaction =0.008).…”

Section: Open Accessmentioning

confidence: 99%

“…Patients receiving positive pressure ventilation appeared to have a lower rate cardiovascular collapse in the fluid bolus group compared with the no fluid bolus group, both among patients receiving non-invasive ventilation for pre-oxygenation (RR 0.51; 95% CI 0.24 to 1.09; p value for interaction =0.032) and among patients receiving bag-mask ventilation between induction and laryngoscopy (RR 0.61; 95% CI 0.33 to 1.13; p value for interaction =0.008). 8 Provision of positive pressure ventilation with a bagmask device between induction and laryngoscopy has been shown to decrease the incidence of severe hypoxaemia during tracheal intubation of intensive care unit (ICU) patients (relative risk, 0.48; 95% CI 0.30 to 0.77). 11 These results, and others examining use of non-invasive ventilation for pre-oxygenation during ICU intubations, 12 suggest that positive pressure ventilation should be provided during tracheal intubation for most critically ill patients.…”

Section: Open Accessmentioning

confidence: 99%

“…In the PrePARE trial, the absolute risk of in-hospital mortality was 16.7% (95% CI 3.4% to 30.0%) higher among patients who experienced cardiovascular collapse during intubation compared with patients who did not. 8…”

Section: Primary Outcomementioning

confidence: 99%

“…Given the findings of the PrePARE trial subgroup analysis (ie, that the effect of fluid bolus administration on cardiovascular collapse may be related to the receipt of positive pressure ventilation during intubation), 8 we will repeat the primary analysis excluding patients who did not receive positive pressure during intubation. Because many critical care patients are already receiving intravenous fluid for other indications when the decision is made to intubate and this may modify the effect of a new fluid bolus, we will repeat the primary analysis excluding patients who were already receiving intravenous fluid at the time of enrolment.…”

Section: Secondary Analyses Of the Primary Outcomementioning

confidence: 99%

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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

et al. 2020

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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 <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 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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Section: Open Accessmentioning

confidence: 99%

Section: Open Accessmentioning

confidence: 99%

Section: Primary Outcomementioning

confidence: 99%

Section: Secondary Analyses Of the Primary Outcomementioning

confidence: 99%

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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

et al. 2020

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“…A recent ESICM taskforce on fluid administration in circulatory dysfunction considered clinical signs of hypoperfusion important in the assessment of both the indication for and efficacy of a fluid challenge [10]. A cautious approach to fluid administration in absence of signs of cardiovascular collapse was supported by the findings of the Pre-PARE trial where 337 critically ill patients requiring tracheal intubation were randomly assigned to either a prophylactic fluid bolus or no fluid bolus [11]. The trial was stopped early for futility as there were no apparent differences in the rates of cardiovascular collapse upon induction between the two groups.…”

mentioning

confidence: 99%

Focus on cardiovascular management in critically ill patients

2020

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Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries

Russotto

Myatra

Laffey

et al. 2021

JAMA

328

178

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Tracheal intubation is one of the most commonly performed and high-risk interventions in critically ill patients. Limited information is available on adverse peri-intubation events.OBJECTIVE To evaluate the incidence and nature of adverse peri-intubation events and to assess current practice of intubation in critically ill patients. DESIGN, SETTING, AND PARTICIPANTSThe International Observational Study to Understand the Impact and Best Practices of Airway Management in Critically Ill Patients (INTUBE) study was an international, multicenter, prospective cohort study involving consecutive critically ill patients undergoing tracheal intubation in the intensive care units (ICUs), emergency departments, and wards, from October 1, 2018, to July 31, 2019 (August 28, 2019, was the final follow-up) in a convenience sample of 197 sites from 29 countries across 5 continents. EXPOSURES Tracheal intubation.MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of major adverse peri-intubation events defined as at least 1 of the following events occurring within 30 minutes from the start of the intubation procedure: cardiovascular instability (either: systolic pressure <65 mm Hg at least once, <90 mm Hg for >30 minutes, new or increase need of vasopressors or fluid bolus >15 mL/kg), severe hypoxemia (peripheral oxygen saturation <80%) or cardiac arrest. The secondary outcomes included intensive care unit mortality. RESULTSOf 3659 patients screened, 2964 (median age, 63 years; interquartile range [IQR], 49-74 years; 62.6% men) from 197 sites across 5 continents were included. The main reason for intubation was respiratory failure in 52.3% of patients, followed by neurological impairment in 30.5%, and cardiovascular instability in 9.4%. Primary outcome data were available for all patients. Among the study patients, 45.2% experienced at least 1 major adverse peri-intubation event. The predominant event was cardiovascular instability, observed in 42.6% of all patients undergoing emergency intubation, followed by severe hypoxemia (9.3%) and cardiac arrest (3.1%). Overall ICU mortality was 32.8%. CONCLUSIONS AND RELEVANCEIn this observational study of intubation practices in critically ill patients from a convenience sample of 197 sites across 29 countries, major adverse peri-intubation events-in particular cardiovascular instability-were observed frequently.

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Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial

Cited by 91 publications

References 33 publications

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

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

Focus on cardiovascular management in critically ill patients

Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries

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