Optimal Ventilation for Cardiac Arrest

NCT07114510 | Recruiting DMC

• 2 other identifiers: 24-0226231R01HD114622-01A1
• Study Type: interventional
• Target: 1,530
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Cardiac Arrest (CA)

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Survival with a favorable neurologic outcome

  Survival to hospital discharge with a favorable neurologic outcome (Pediatric Cerebral Performance Category (PCPC) score (scored on a scale of 1-6) at hospital discharge of 1 (normal), 2 (mild disability) or no worse than baseline). Percentage of subjects in control vs. intervention will be compared.

  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 Outcomes (1)

• Ventilation rate

  Two minutes after CPR start through end of CPR

Other Outcomes (9)

• Return of spontaneous circulation (ROSC) lasting >20 minutes

  Duration of CPR event through 20 minutes after CPR

• Return of circulation (via ROSC or eCPR)

  Duration of CPR event through 20 minutes after CPR

• Survival to discharge

  From cardiac arrest to hospital discharge, estimated average of 6-12 months

Study Arms (14)

Control

EXPERIMENTAL

Standard ICU resuscitation practices throughout study

Other: None - control

OPTI-VENT Bundle

EXPERIMENTAL

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 ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.

Other: OPTI-VENT Bundle

Site 5

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 6

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 7

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 8

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 9

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 10

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 11

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 12

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 13

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 14

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 15

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Site 16

EXPERIMENTAL

Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.

Other: OPTI-VENT Bundle; Other: Transition; Other: None - control

Interventions

OPTI-VENT Bundle OTHER

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 ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.

OPTI-VENT Bundle; Site 10; Site 11; Site 12; Site 13; Site 14; Site 15; Site 16; Site 5; Site 6; Site 7; Site 8; Site 9

Transition OTHER

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.

Site 10; Site 11; Site 12; Site 13; Site 14; Site 15; Site 16; Site 5; Site 6; Site 7; Site 8; Site 9

None - control OTHER

Control - no intervention

Control; Site 10; Site 11; Site 12; Site 13; Site 14; Site 15; Site 16; Site 5; Site 6; Site 7; Site 8; Site 9

Eligibility Criteria

• Age: 37 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Utah: collaborator
• Villanova University: collaborator

Study Sites (20)

CHOC

Orange, California, 92868, United States

RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

Children's Hospital Colorado

Denver, Colorado, 80045, United States

RECRUITING

Nemours Children's Health

Wilmington, Delaware, 19803, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30303, United States

RECRUITING

Riley Children's Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

UNC Children's Hospital

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Dell Children's Medical Center

Austin, Texas, 78723, United States

RECRUITING

Medical City Children's Hospital

Dallas, Texas, 75230, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23219, United States

RECRUITING

Seattle Children's

Seattle, Washington, 98105, United States

RECRUITING

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (19)

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  PMID: 15582757 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Intensive Care Quality of Cardio-Pulmonary Resuscitation) Investigators. Association Between Diastolic Blood Pressure During Pediatric In-Hospital Cardiopulmonary Resuscitation and Survival. Circulation. 2018 Apr 24;137(17):1784-1795. doi: 10.1161/CIRCULATIONAHA.117.032270. Epub 2017 Dec 26.

  PMID: 29279413 BACKGROUND

• 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; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN). Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial. Trials. 2018 Apr 3;19(1):213. doi: 10.1186/s13063-018-2590-y.

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• 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, Naim MY, Palmer CA, Schneiter C, Sharron MP, Siems A, Srivastava N, Tabbutt S, Tilford B, Viteri S, Berg RA, Bell MJ, Carcillo JA, Carpenter TC, Dean JM, Fink EL, Hall M, McQuillen PS, Meert KL, Mourani PM, Notterman D, Pollack MM, Sapru A, Wessel D, Yates AR, Zuppa AF. Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial. JAMA. 2022 Mar 8;327(10):934-945. doi: 10.1001/jama.2022.1738.

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• Aufderheide TP, Sigurdsson G, Pirrallo RG, Yannopoulos D, McKnite S, von Briesen C, Sparks CW, Conrad CJ, Provo TA, Lurie KG. Hyperventilation-induced hypotension during cardiopulmonary resuscitation. Circulation. 2004 Apr 27;109(16):1960-5. doi: 10.1161/01.CIR.0000126594.79136.61. Epub 2004 Apr 5.

  PMID: 15066941 BACKGROUND

• Aufderheide TP, Lurie KG. Death by hyperventilation: a common and life-threatening problem during cardiopulmonary resuscitation. Crit Care Med. 2004 Sep;32(9 Suppl):S345-51. doi: 10.1097/01.ccm.0000134335.46859.09.

  PMID: 15508657 BACKGROUND

• Grieco DL, J Brochard L, Drouet A, Telias I, Delisle S, Bronchti G, Ricard C, Rigollot M, Badat B, Ouellet P, Charbonney E, Mancebo J, Mercat A, Savary D, Richard JM. Intrathoracic Airway Closure Impacts CO2 Signal and Delivered Ventilation during Cardiopulmonary Resuscitation. Am J Respir Crit Care Med. 2019 Mar 15;199(6):728-737. doi: 10.1164/rccm.201806-1111OC.

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• Chapman JD, Geneslaw AS, Babineau J, Sen AI. Improving Ventilation Rates During Pediatric Cardiopulmonary Resuscitation. Pediatrics. 2022 Sep 1;150(3):e2021053030. doi: 10.1542/peds.2021-053030.

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• Topjian AA, Raymond TT, Atkins D, Chan M, Duff JP, Joyner BL Jr, Lasa JJ, Lavonas EJ, Levy A, Mahgoub M, Meckler GD, Roberts KE, Sutton RM, Schexnayder SM; Pediatric Basic and Advanced Life Support Collaborators. Part 4: Pediatric Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S469-S523. doi: 10.1161/CIR.0000000000000901. Epub 2020 Oct 21. No abstract available.

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• Nadkarni VM, Larkin GL, Peberdy MA, Carey SM, Kaye W, Mancini ME, Nichol G, Lane-Truitt T, Potts J, Ornato JP, Berg RA; National Registry of Cardiopulmonary Resuscitation Investigators. First documented rhythm and clinical outcome from in-hospital cardiac arrest among children and adults. JAMA. 2006 Jan 4;295(1):50-7. doi: 10.1001/jama.295.1.50.

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• Wolfe H, Zebuhr C, Topjian AA, Nishisaki A, Niles DE, Meaney PA, Boyle L, Giordano RT, Davis D, Priestley M, Apkon M, Berg RA, Nadkarni VM, Sutton RM. Interdisciplinary ICU cardiac arrest debriefing improves survival outcomes*. Crit Care Med. 2014 Jul;42(7):1688-95. doi: 10.1097/CCM.0000000000000327.

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• Girotra S, Nallamothu BK, Spertus JA, Li Y, Krumholz HM, Chan PS; American Heart Association Get with the Guidelines-Resuscitation Investigators. Trends in survival after in-hospital cardiac arrest. N Engl J Med. 2012 Nov 15;367(20):1912-20. doi: 10.1056/NEJMoa1109148.

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• Holmberg MJ, Ross CE, Fitzmaurice GM, Chan PS, Duval-Arnould J, Grossestreuer AV, Yankama T, Donnino MW, Andersen LW; American Heart Association's Get With The Guidelines-Resuscitation Investigators. Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the United States. Circ Cardiovasc Qual Outcomes. 2019 Jul 9;12(7):e005580.

  PMID: 31545574 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Sutton, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHOP RSC Clinical Research Program Manager

CONTACT

215-590-1859; grahamk1@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (20)