Pre-ROSC Intra-Nasal Cooling Effectiveness (PRINCE)

June 8, 2011 updated by: BeneChill, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • CHU St Pierre
      • Brussels, Belgium, 1070
        • Erasme Hospital (Free University of Brussels)
      • La Louviere, Belgium, 7100
        • CHU de Tivoli
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg Leuven
      • Liege, Belgium, 4000
        • CHR de la Citadelle
      • Roeselare, Belgium, 8800
        • Helig Hartzieknehuis Roeselare
  • Czech Republic
      • Prague, Czech Republic, 10034
        • Faculty Hospital Kralovske Vinohrady
  • Germany
      • Aachen, Germany, 52146
        • Medizinisches Zentrum Kreis Aachen gGmbH
      • Berlin, Germany, 13353
        • Charite Campus Virchow Klinikum
      • Freiburg, Germany, 79106
        • Albert Ludwigs University Freiburg
      • Göttingen, Germany, 37086
        • Georg August-Universität Göttingen
      • Halle (Saale), Germany, 06120
        • Krankenhaus Martha-Maria Halle-Dölau gGmbH
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universität Magdeburg
  • Italy
      • Monza, Italy, 20052
        • A.O Ospedale San Gerardo di Monza
  • Sweden
      • Stockholm, Sweden, 118 83
        • Stockholm Prehospital Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RhinoChill
Intra-arrest cooling with the RhinoChill during advanced cardiac life support
Device: RhinoChill
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Other Names:
  • intra-nasal cooling
Other: Control
Advanced cardiac life support, only
Other: Control
Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-hour after arrest
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.
30 days after arrest
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."

  1. - Good cerebral performance: little to no deficit.
  2. - Moderate cerebral disability: capable of independent activities of daily life
  3. - Severe cerebral disability: conscious, but dependent on others for daily support
  4. - Coma or vegetative state
  5. - Death or brain death
30-days after arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcomes in Sub-group With VF/VT as First Rhythm
Time Frame: hospital discharge
ROSC, survival, and neurologically-intact survival
hospital discharge
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.
within 8 hours after enrollment
Length of Stay
Time Frame: Hospital Discharge

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

  1. Days on ventilator
  2. Days in intensive care without ventilator
  3. Days in general ward
Hospital Discharge
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.
7 days after arrest
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.
24 hours after arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeneChill, Inc

Investigators

  • Study Chair: Denise Barbut, MD, BeneChill, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 11, 2008

First Submitted That Met QC Criteria

December 11, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-CP1012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe