Cardiac ArrestPRINCENCT00808236
Pre-ROSC Intra-Nasal Cooling Effectiveness
A study testing RhinoChill in people with Cardiac Arrest, run by BeneChill, Inc at 15 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- RhinoChill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Nov 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Collapse was witnessed
- No pulse
- Unresponsive to external stimuli
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Belgium6 sites
CHU St Pierre
Brussels, 1000
Erasme Hospital (Free University of Brussels)
Brussels, 1070
CHU de Tivoli
La Louvière, 7100
UZ Gasthuisberg Leuven
Leuven, B-3000
CHR de la Citadelle
Liège, 4000
Helig Hartzieknehuis Roeselare
Roeselare, 8800
Germany6 sites
Medizinisches Zentrum Kreis Aachen gGmbH
Aachen, 52146
Charite Campus Virchow Klinikum
Berlin, 13353
Albert Ludwigs University Freiburg
Freiburg im Breisgau, 79106
Georg August-Universität Göttingen
Göttingen, 37086
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 06120
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- RhinoChill, Control
- Keywords
- Cardiac Arrest, Pre-hospital, Mild hypothermia, Resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinoChillDevice
Also called intra-nasal cooling
Nasal catheters are placed and cooling is begun during the resuscitation attempt
ControlOther
Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines
| Study group | Role | What they receive |
|---|---|---|
| RhinoChill | Experimental | Intra-arrest cooling with the RhinoChill during advanced cardiac life support Receives: Device: RhinoChill |
| Control | Other | Advanced cardiac life support, only Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve Return of Spontaneous Circulation (ROSC)
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.
Measured: 1-hour after arrest
Survived to Hospital Discharge
The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.
Measured: 30 days after arrest
Survived Neurologically-Intact
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
Measured: 30-days after arrest
Secondary outcomes (5)
Primary Outcomes in Sub-group With VF/VT as First Rhythm
ROSC, survival, and neurologically-intact survival
Measured: hospital discharge
Time to Therapeutic Temperature
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.
Measured: within 8 hours after enrollment
Length of Stay
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
Measured: Hospital Discharge
Serious Adverse Events (SAEs)
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.
Measured: 7 days after arrest
24-hour Adverse Events (AE)
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.
Measured: 24 hours after arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeneChill, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Denise Barbut, MD, Study chair, BeneChill, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808236
- Sponsor's protocol ID
- BC-CP1012
- Acronym
- PRINCE
- Status last verified
- Jun 2011
- First submitted
- 11 Dec 2008
- Last updated
- 10 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tsai MS, Barbut D, Tang W, Wang H, Guan J, Wang T, Sun S, Inderbitzen B, Weil MH. Rapid head cooling initiated coincident with cardiopulmonary resuscitation improves success of defibrillation and post-resuscitation myocardial function in a porcine model of prolonged cardiac arrest. J Am Coll Cardiol. 2008 May 20;51(20):1988-90. doi: 10.1016/j.jacc.2007.12.057. No abstract available.
PubMed 18482670Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
PubMed 20679548
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
- ClinicalTrials.gov ID
- NCT00808236
- Acronym / sponsor ID
- PRINCE / BC-CP1012
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Pre-hospital, Mild hypothermia, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BeneChill, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Posted 16 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RhinoChill | Experimental | Device: RhinoChillIntra-arrest cooling with the RhinoChill during advanced cardiac life support |
| Control | Other | Other: ControlAdvanced cardiac life support, only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- Collapse was witnessed
- No pulse
- Unresponsive to external stimuli
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinoChillAlso: intra-nasal coolingNasal catheters are placed and cooling is begun during the resuscitation attempt | Device | RhinoChill |
| ControlAdvanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines | Other | Control |
Primary outcome
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." 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
5 secondary outcomes
Primary Outcomes in Sub-group With VF/VT as First Rhythm
Time frame: hospital discharge
Time to Therapeutic Temperature
Time frame: within 8 hours after enrollment
Length of Stay
Time frame: Hospital Discharge
Serious Adverse Events (SAEs)
Time frame: 7 days after arrest
24-hour Adverse Events (AE)
Time frame: 24 hours after arrest
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18482670Tsai MS, Barbut D, Tang W, Wang H, Guan J, Wang T, Sun S, Inderbitzen B, Weil MH. Rapid head cooling initiated coincident with cardiopulmonary resuscitation improves success of defibrillation and post-resuscitation myocardial function in a porcine model of prolonged cardiac arrest. J Am Coll Cardiol. 2008 May 20;51(20):1988-90. doi: 10.1016/j.jacc.2007.12.057. No abstract available.
- Derived from this study: PubMed 20679548Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Barbut, MD study chair
BeneChill, Inc
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RhinoChill in people with Cardiac Arrest, run by BeneChill, Inc at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Germany, Czechia, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve Return of Spontaneous Circulation (ROSC) (time frame: 1-hour after arrest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.