Cardiac Arrest
Conditions
Keywords
Pre-hospital hypothermia, Induced therapeutic hypothermia, Cardiac arrest
Brief summary
The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.
Detailed description
Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6 The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting. This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.
Interventions
induced therapeutic hypothermia
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH
Exclusion criteria
* Less than 18 * Cardiac arrest due to trauma or hemorrhage * Pregnant women * patients whom are already hypothermic * transported to a hospital that can not maintain hypothermia for 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induced therapeutic hypothermia in the pre-hospital setting improves outcomes | followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated | Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regular treatment without induced therapeutic hypothermia | followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated | Patients will be treated under standing paramedic protocols without the induction of hypothermia. To determine if there is a difference in these outcomes in patients with prolonged transport to the hospital (\> 20 minutes) versus those with shorter transport times. |
Countries
United States
Outcome results
None listed