N/A
Completed N=200
Pre-ROSC Intra-Nasal Cooling Effectiveness
Source: ClinicalTrials.gov NCT00808236 ↗Enrolled (actual)
200
Serious AEs
—
Results posted
Jul 2010
Primary outcomePrimary: Achieve Return of Spontaneous Circulation (ROSC) — 33; 43 participants
Summary
The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would increase ROSC and subsequent survival. The study was not powered to demonstrate statistically-significant differences in any outcome parameter, but was intended as an exploratory study only.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achieve Return of Spontaneous Circulation (ROSC) |
33; 43 | — |
| PRIMARY Survived to Hospital Discharge |
14; 13 | — |
| PRIMARY Survived Neurologically-Intact |
11; 9 | — |
| SECONDARY Primary Outcomes in Sub-group With VF/VT as First Rhythm |
17; 21; 10; 10; 8; 6 | — |
| SECONDARY Time to Therapeutic Temperature |
102; 291; 155; 284; 170; 377 | — |
| SECONDARY Length of Stay |
3.0; 2.6; 4.2; 8.8; 2.0; 3.0 | — |
| SECONDARY Serious Adverse Events (SAEs) |
6; 12 | — |
| SECONDARY 24-hour Adverse Events (AE) |
17; 0; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- ≥18 years
- Collapse was witnessed
- No pulse
- Unresponsive to external stimuli
Exclusion Criteria
- Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose (OD), cerebrovascular accident (CVA), drowning, smoke inhalation, electrocution, hanging
- Already hypothermic
- Head trauma
- Cannot place intra nasal catheters
- Do Not Attempt to Resuscitate (DNAR) orders
- Known or clinically apparent pregnancy
- Have a known coagulopathy (except therapeutically induced)
- Are known to have a need for supplemental oxygen
- Achieve return of spontaneous circulation (ROSC) prior to initiating cooling
- Are reached by emergency medical services (EMS) personnel more than 20 minutes after collapse
Data sourced from ClinicalTrials.gov (NCT00808236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.