Pre-ROSC Intra-Nasal Cooling Effectiveness (PRINCE)
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| ClinicalTrials.gov Identifier: NCT00808236 |
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Recruitment Status :
Completed
First Posted : December 15, 2008
Results First Posted : July 16, 2010
Last Update Posted : June 10, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Arrest | Device: RhinoChill Other: Control | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | September 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: RhinoChill
Intra-arrest cooling with the RhinoChill during advanced cardiac life support
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Device: RhinoChill
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Other Name: intra-nasal cooling |
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Control
Advanced cardiac life support, only
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Other: Control
Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines |
- 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.
- 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.
- 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
- Primary Outcomes in Sub-group With VF/VT as First Rhythm [ Time Frame: hospital discharge ]ROSC, survival, and neurologically-intact survival
- 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.
- 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
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808236
| Belgium | |
| CHU St Pierre | |
| Brussels, Belgium, 1000 | |
| Erasme Hospital (Free University of Brussels) | |
| Brussels, Belgium, 1070 | |
| CHU de Tivoli | |
| La Louviere, Belgium, 7100 | |
| UZ Gasthuisberg Leuven | |
| Leuven, Belgium, B-3000 | |
| CHR de la Citadelle | |
| Liege, Belgium, 4000 | |
| Helig Hartzieknehuis Roeselare | |
| Roeselare, Belgium, 8800 | |
| Czech Republic | |
| Faculty Hospital Královské Vinohrady | |
| Prague, Czech Republic, 10034 | |
| Germany | |
| Medizinisches Zentrum Kreis Aachen gGmbH | |
| Aachen, Germany, 52146 | |
| Charite Campus Virchow Klinikum | |
| Berlin, Germany, 13353 | |
| Albert Ludwigs University Freiburg | |
| Freiburg, Germany, 79106 | |
| Georg August-Universität Göttingen | |
| Göttingen, Germany, 37086 | |
| Krankenhaus Martha-Maria Halle-Dölau gGmbH | |
| Halle (Saale), Germany, 06120 | |
| Otto-von-Guericke-Universität Magdeburg | |
| Magdeburg, Germany, 39120 | |
| Italy | |
| A.O Ospedale San Gerardo di Monza | |
| Monza, Italy, 20052 | |
| Sweden | |
| Stockholm Prehospital Centrum | |
| Stockholm, Sweden, 118 83 | |
| Study Chair: | Denise Barbut, MD | BeneChill, Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Becky Inderbitzen/Vice President Clinical Affairs, BeneChill |
| ClinicalTrials.gov Identifier: | NCT00808236 |
| Other Study ID Numbers: |
BC-CP1012 |
| First Posted: | December 15, 2008 Key Record Dates |
| Results First Posted: | July 16, 2010 |
| Last Update Posted: | June 10, 2011 |
| Last Verified: | June 2011 |
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Cardiac Arrest Pre-hospital Mild hypothermia Resuscitation |
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Heart Arrest Heart Diseases Cardiovascular Diseases |