Pediatric Out-of-Hospital Cardiac Arrest
Conditions
Keywords
cardiac arrest, IM Epinephrine, standard of care, pediatric, resuscitation
Brief summary
This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).
Detailed description
IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.
Interventions
Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Paramedic services across Ontario will participate in the study. All sites will begin with a period of baseline data collection (standard of care arm) and will cross over to the intervention arm (Intramuscular Epinephrine Dose arm) on a staggered schedule and in random order. Each site will remain in the intervention arm, once cross over happens, for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA) * Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)
Exclusion criteria
\- Children who experience OHCA due to an obvious traumatic event.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to initial return of spontaneous circulation (ROSC) | At time of event | The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to sustained ROSC | At time of event | Time to sustained ROSC will be calculated from the time that paramedics arrive on scene to the time that sustained ROSC, defined as chest compressions not required for 20 minutes with persistent signs of circulation, is achieved. |
| Survival | From time of event to ED admission | Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED |
| Survival - comparison between both arms | From time of event to hospital admission | Survival to hospital admission will be compared between standard of care and intervention periods |
| PCCU/Hospital length of stay | From time of hospital/PCCU admission to discharge, up to 1 year | PCCU and hospital length of stay will be calculated from time of admission to the PCCU/hospital and time to discharge from PCCU/hospital, if applicable, between standard of care and intervention periods |
| Return of spontaneous circulation | At time of event | Whether return of spontaneous circulation is achieved or not |
| Post POHCA survival | Dependent on survival at 6 and 12 month period post POHCA event | Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods |
| Neurological status | From time of discharge and 6 and 12 months post POHCA event | The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods |
| Life Impact and Pediatric Quality of Life assessments | 6 and 12 months post POHCA event | Life Impact assessment between 6 and 12 months: the investigator will use the Pediatric Quality of Life (PEDSQoL, Pediatrics Quality of Life) assessment tool at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. The score ranges from 0-100, with higher scores indicating better outcome. |
| Survival to hospital discharge | Dependent on course of hospital stay, up to 1 year | Survival to hospital discharge will be compared between standard of care and intervention periods |
Countries
Canada
Contacts
Primary ContactMaysaa Assaf
Outcome results
None listed