N/A N=200 Randomized Single-blind Treatment

Pre-ROSC Intra-Nasal Cooling Effectiveness

Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT00808236 ↗

Enrolled (actual)

200

Serious AEs

—

Results posted

Jul 2010

Primary outcome: Primary: Achieve Return of Spontaneous Circulation (ROSC) — 33; 43 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RhinoChill (Device); Control (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: BeneChill, Inc
Primary completion: Jun 2009

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	—

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.

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

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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.