Optimal Ventilation for Cardiac Arrest (OPTI-VENT)
Status
Enrolling
Conditions
Cardiac Arrest (CA)
Treatments
Other: OPTI-VENT Bundle
Other: None - control
Other: Transition
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Enrollment
1,530 estimated patients
Sex
All
Ages
37 weeks to 18 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,530 participants in 14 patient groups
Control
Experimental group
Description:
Standard ICU resuscitation practices throughout study
Treatment:
Other: None - control
OPTI-VENT Bundle
Experimental group
Description:
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.
Treatment:
Other: OPTI-VENT Bundle
Site 5
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 6
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 7
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 8
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 9
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 10
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 11
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 12
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 13
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 14
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 15
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Site 16
Experimental group
Description:
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.
Treatment:
Other: Transition
Other: None - control
Other: OPTI-VENT Bundle
Trial contacts and locations
20
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Central trial contact
CHOP RSC Clinical Research Program Manager
Data sourced from clinicaltrials.gov
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