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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 18
Healthy Volunteers: f
View:

• Invasive airway in place at the start of CPR or airway placed within the first 5 minutes

• Received at least 1 minute of CPR.

Locations
United States
California
CHOC
RECRUITING
Orange
Lucile Packard Children's Hospital Stanford
RECRUITING
Palo Alto
Colorado
Children's Hospital Colorado
RECRUITING
Denver
Delaware
Nemours Children's Health
RECRUITING
Wilmington
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Iowa
Stead Family Children's Hospital
RECRUITING
Iowa City
Indiana
Riley Children's Health
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Missouri
Washington University in St. Louis
RECRUITING
St Louis
North Carolina
UNC Children's Hospital
RECRUITING
Chapel Hill
New York
Cohen Children's Medical Center
RECRUITING
New Hyde Park
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Dell Children's Medical Center
RECRUITING
Austin
Medical City Children's Hospital
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Virginia
Children's Hospital of Richmond at VCU
RECRUITING
Richmond
Washington
Seattle Children's
RECRUITING
Seattle
Wisconsin
Children's Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
CHOP RSC Clinical Research Program Manager
grahamk1@chop.edu
215-590-1859
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 1530
Treatments
Experimental: Control
Standard ICU resuscitation practices throughout study
Experimental: 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 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.
Experimental: Site 5
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.
Experimental: Site 6
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.
Experimental: Site 7
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.
Experimental: Site 8
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.
Experimental: Site 9
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.
Experimental: Site 10
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.
Experimental: Site 11
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.
Experimental: Site 12
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.
Experimental: Site 13
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.
Experimental: Site 14
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.
Experimental: Site 15
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.
Experimental: Site 16
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: University of Utah, Villanova University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov