Cardiac Arrest (CA)
Conditions
Keywords
Pediatric
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.
Interventions
OTHEROPTI-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.
OTHERTransition
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.
OTHERNone - control
Control - no intervention
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
Villanova University
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival with a favorable neurologic outcome | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation rate | Two minutes after CPR start through end of CPR | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival to discharge | From cardiac arrest to hospital discharge, estimated average of 6-12 months | Percentage of subjects surviving to discharge in control vs. intervention will be compared. |
| Survival with no new morbidity (change in Functional Status Score (FSS) from baseline of < 3 points) | 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 | FSS is scored on a scale of 1-5 (lower number is better function) across 6 functional categories (mental status, sensory, communication, motor function, feeding, respiratory). Percentage of subjects surviving with no new morbidity in control vs. intervention will be compared. |
| Intra-arrest cerebral oxygen saturation | Duration of CPR event | Intra-arrest cerebral oxygen saturation as a continuous variable will be compared between intervention and control. |
| Return of spontaneous circulation (ROSC) lasting >20 minutes | Duration of CPR event through 20 minutes after CPR | Percentage of events achieving ROSC in control vs. intervention will be compared. |
| Intra-Arrest Diastolic Blood Pressure (DBP) Target | Duration of CPR | Percentage of patients achieving DBP targets (\>25mmHg in infants \< 1 year of age; \>30mmHg in older children) will be compared between control vs. intervention. |
| Hyperoxia (PaO2 >300 mmHg) | During the first 24 hours after return of circulation. | Percentage of subjects in control vs. intervention will be compared. |
| Hypocarbia (PaCO2 <30 mmHg) | During the first 24 hours after return of circulation. | Percentage of subjects in control vs. intervention will be compared. |
| Intra-arrest diastolic blood pressure (DBP) | Duration of CPR event | Invasive arterial blood pressure (mmHg) as a continuous variable will be compared between intervention and control. |
| Return of circulation (via ROSC or eCPR) | Duration of CPR event through 20 minutes after CPR | Percentage of events achieving return of circulation in control vs. intervention will be compared. |
Countries
United States
Contacts
Primary ContactCHOP RSC Clinical Research Program Manager
Outcome results
None listed