Optimal Ventilation for Cardiac Arrest

Children's Hospital of Philadelphia1,530 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,530

Conditions

Cardiac Arrest (CA)

Interventions

OPTI-VENT BundleOTHER

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.

TransitionOTHER

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.

Eligibility

Sex: ALLMin age: 37 WeeksMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

CHOC

Orange, California, United States

Outcomes

Primary Outcomes

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.

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 Outcomes

Ventilation rate

Intra-arrest ventilation rate between 18 - 32 breaths per minute. Ventilation rate will be calculated as an event average, excluding the first two minutes of the event. Percentage of events achieving target in control vs. intervention will be compared.

Time frame: Two minutes after CPR start through end of CPR

Central Contacts

CHOP RSC Clinical Research Program Manager

CONTACT

215-590-1859 grahamk1@chop.edu

Data from ClinicalTrials.gov

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