Skip to main content
OpenTrials
Completed

NCT Number: NCT00808236

Pre-ROSC Intra-Nasal Cooling Effectiveness

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU St Pierre, Brussels, Belgium

Loading trial locations.

About this study

Out of hospital cardiac arrest remains a significant cause of death. Mild hypothermia induced after resuscitation from cardiac arrest has been shown to improve neurologically intact survival. Studies in dogs and rodents have demonstrated improved outcomes when cooling is initiated intra-arrest.

The RhinoChill is a non-invasive cooling device through which rapid cooling is achieved via the intranasal delivery of an evaporative coolant into the nasopharynx. Due to its non-invasive and portable nature, the RhinoChill can be used to begin cooling earlier than other cooling devices.

Studies performed using the RhinoChill in a porcine model of cardiac arrest suggest that cooling with the RhinoChill prior to the first defibrillation attempt facilitates resuscitation and improves resuscitation rate and neurologically intact survival.

This study is being performed to assess the feasibility of using the RhinoChill device in the pre-hospital setting to improve resuscitation from cardiac arrest.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RhinoChill

Device

Nasal catheters are placed and cooling is begun during the resuscitation attempt

Other names: intra-nasal cooling

Control

Other

Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines

Primary outcomes

  1. Achieve Return of Spontaneous Circulation (ROSC)

    Time frame: 1-hour after arrest

    ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.

  2. Survived to Hospital Discharge

    Time frame: 30 days after arrest

    The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.

  3. Survived Neurologically-Intact

    Time frame: 30-days after arrest

    The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact."

    • - Good cerebral performance: little to no deficit.
    • - Moderate cerebral disability: capable of independent activities of daily life
    • - Severe cerebral disability: conscious, but dependent on others for daily support
    • - Coma or vegetative state
    • - Death or brain death

Secondary outcomes

  1. Primary Outcomes in Sub-group With VF/VT as First Rhythm

    Time frame: hospital discharge

    ROSC, survival, and neurologically-intact survival

  2. Time to Therapeutic Temperature

    Time frame: within 8 hours after enrollment

    The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.

  3. Length of Stay

    Time frame: Hospital Discharge

    Length of stay data for patients admitted to the hospital will be calculated for:

    • Days on ventilator
    • Days in intensive care without ventilator
    • Days in general ward

  4. Serious Adverse Events (SAEs)

    Time frame: 7 days after arrest

    These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.

  5. 24-hour Adverse Events (AE)

    Time frame: 24 hours after arrest

    These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.

Sponsors and collaborators

Lead sponsor

BeneChill, Inc

Industry

Registry information

Official study title

Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study

Acronym: PRINCE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.