Optimal Ventilation for Cardiac Arrest

Official title

OPTImal Ventilation to Improve Pediatric Cardiac Arrest Outcomes (OPTI-VENT)

Overview

Pediatric cardiac arrest is a life-threatening problem affecting \>15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome (Pediatric Cerebral Performance Category Score 1-2 or no change from baseline) among children receiving at least 1 minute of CPR.

Interventions

• Other OPTI-VENT Bundle
  Provider Education: During a brief (\<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current v
• Other Transition
  There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
• Other None - control
  Control - no intervention

Primary outcome measures

• Survival with a favorable neurologic outcome [Time frame: From baseline (assessed prior to admission, or new in-hospital baseline assessed no more than 30 days prior to cardiac arrest for patients hospitalized >90 days) to the assessment at hospital discharge, estimated average of 6-12 months]

Secondary outcome measures (1)

• Ventilation rate [Time frame: Two minutes after CPR start through end of CPR]

Eligibility criteria

Inclusion criteria

• Invasive airway in place at the start of CPR or airway placed within the first 5 minutes
• Received at least 1 minute of CPR.

Exclusion criteria

• Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care.
• Brain death determination prior to the CPR event.
• Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes).
• Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 20 centers

• CHOC — Orange
• Lucile Packard Children's Hospital Stanford — Palo Alto
• Children's Hospital Colorado — Denver
• Nemours Children's Health — Wilmington
• Children's Healthcare of Atlanta — Atlanta
• Riley Children's Health — Indianapolis
• Stead Family Children's Hospital — Iowa City
• Boston Children's Hospital — Boston
• … and 12 more centers

Publications

• Jacobs I, Nadkarni V, Bahr J, Berg RA, Billi JE, Bossaert L, Cassan P, Coovadia A, D'Este K, Finn J, Halperin H, Handley A, Herlitz J, Hickey R, Idris A, Kloeck W, Larkin GL, Mancini ME, Mason P, Mears G, Monsieurs K, Montgomery W, Morley P, Nichol G, Nolan J, Okada K, Perlman J, Shuster M, Steen PA, Sterz F, Tibballs J, Timerman S, Truitt T, Zideman D; International Liason Committee on Resusitati PMID 15582757
• Niles DE, Dewan M, Zebuhr C, Wolfe H, Bonafide CP, Sutton RM, DiLiberto MA, Boyle L, Napolitano N, Morgan RW, Stinson H, Leffelman J, Nishisaki A, Berg RA, Nadkarni VM. A pragmatic checklist to identify pediatric ICU patients at risk for cardiac arrest or code bell activation. Resuscitation. 2016 Feb;99:33-7. doi: 10.1016/j.resuscitation.2015.11.017. Epub 2015 Dec 17. PMID 26703460
• Pollack MM, Holubkov R, Glass P, Dean JM, Meert KL, Zimmerman J, Anand KJ, Carcillo J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Functional Status Scale: new pediatric outcome measure. Pediatrics. 2009 Jul;124(1):e18-28. doi: 10.1542/peds.2008-1987. PMID 19564265
• Pollack MM, Holubkov R, Funai T, Clark A, Moler F, Shanley T, Meert K, Newth CJ, Carcillo J, Berger JT, Doctor A, Berg RA, Dalton H, Wessel DL, Harrison RE, Dean JM, Jenkins TL. Relationship between the functional status scale and the pediatric overall performance category and pediatric cerebral performance category scales. JAMA Pediatr. 2014 Jul;168(7):671-6. doi: 10.1001/jamapediatrics.2013.5316 PMID 24862461
• Del Castillo J, Lopez-Herce J, Matamoros M, Canadas S, Rodriguez-Calvo A, Cechetti C, Rodriguez-Nunez A, Alvarez AC; Iberoamerican Pediatric Cardiac Arrest Study Network RIBEPCI. Hyperoxia, hypocapnia and hypercapnia as outcome factors after cardiac arrest in children. Resuscitation. 2012 Dec;83(12):1456-61. doi: 10.1016/j.resuscitation.2012.07.019. Epub 2012 Jul 25. PMID 22841610
• Berg RA, Sutton RM, Reeder RW, Berger JT, Newth CJ, Carcillo JA, McQuillen PS, Meert KL, Yates AR, Harrison RE, Moler FW, Pollack MM, Carpenter TC, Wessel DL, Jenkins TL, Notterman DA, Holubkov R, Tamburro RF, Dean JM, Nadkarni VM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) PICqCPR (Pediatric Inten PMID 29279413
• Reeder RW, Girling A, Wolfe H, Holubkov R, Berg RA, Naim MY, Meert KL, Tilford B, Carcillo JA, Hamilton M, Bochkoris M, Hall M, Maa T, Yates AR, Sapru A, Kelly R, Federman M, Michael Dean J, McQuillen PS, Franzon D, Pollack MM, Siems A, Diddle J, Wessel DL, Mourani PM, Zebuhr C, Bishop R, Friess S, Burns C, Viteri S, Hehir DA, Whitney Coleman R, Jenkins TL, Notterman DA, Tamburro RF, Sutton RM; Eu PMID 29615134
• ICU-RESUS and Eunice Kennedy Shriver National Institute of Child Health; Human Development Collaborative Pediatric Critical Care Research Network Investigator Groups; Sutton RM, Wolfe HA, Reeder RW, Ahmed T, Bishop R, Bochkoris M, Burns C, Diddle JW, Federman M, Fernandez R, Franzon D, Frazier AH, Friess SH, Graham K, Hehir D, Horvat CM, Huard LL, Landis WP, Maa T, Manga A, Morgan RW, Nadkarni VM, PMID 35258533

Identifiers

NCT: NCT07114510 · 24-022623 · 1R01HD114622-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗