Out-of-hospital Cardiac ArrestPhase 2PRINCESSNCT01400373
Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
A Phase 2 study testing Prehospital intra-nasal cooling with RhinoChill in people with Out-of-hospital Cardiac Arrest, run by Karolinska Institutet at 2 sites in 2 countries.
Trial summary
Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010. The main purpose of this study is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- Prehospital intra-nasal cooling with RhinoChill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jul 2010to 30 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Collapse was witnessed (heard or seen)
- Do not have a pulse
- Are unresponsive to external stimuli
Who cannot join
- Age ≥80 years
- Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose, cerebrovascular accident, drowning, smoke inhalation, electrocution, hanging
- Already hypothermic (e.g., avalanche victim; found in the snow)
- Have an obvious barrier to placing intra nasal catheters (e.g., intranasal obstruction)
- Do Not Attempt to Resuscitate (DNAR) orders
- Have a terminal disease
Show all 11Show fewer
- Known or clinically apparent pregnancy
- Have a known coagulopathy (except therapeutically induced)
- Are known to have a need for supplemental oxygen
- Achieve ROSC prior to randomization
- Response time (call to arrival) of the ambulance > 15 minutes
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Department of Intensive Care, Erasme University Hospital
Brussels
Sweden1 site
Department of Cardiology, Karolinska Institutet, Södersjukhuset
Stockholm, 11883
About this study
Official title: PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010.
The main purpose of this study is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.
Read the detailed description
Background:
The RhinoChill Device is a non-invasive, portable cooling device through which rapid cooling is achieved via the trans-nasal delivery of an evaporative coolant into the nasopharynx. Animal studies suggest a life-saving benefit for intra-arrest cooling.
Results from a European multicenter randomized trial (PRINCE - Pre Rosc Intra Nasal Cooling Effectiveness), published in Circulation in August 2010, demonstrate that intra-arrest trans-nasal evaporative cooling can be used safely and effectively in prehospital cardiac arrest without interfering with advanced cardiac life support protocols.
The outcome results among patients admitted to hospital showed a trend towards improved survival to hospital discharge in the treatment group (43.8% versus 31.0, p=0.26). The difference in neurologically intact survival was 34.4% vs 21.4%). In the subgroup of patients where cardiopulmonary resuscitation (CPR) was started by Emergency Medical Services personnel within 10 minutes (78 % of total number of patients) the difference in total survival between the groups was (56.5 versus 29.4, p=0.03). Neurologically intact survival for the corresponding subgroup was 43.5% vs 17.6%. In the treatment group, time to tympanic temperature of 34º was reached 3 hours faster (102 min versus 291 min, p=0.03) and time to core temperature 2 hours faster (155 min versus 284 min, p=0.13).
This study is powered to detect clinically significant changes in neurologically intact survival at 90 days after cardiac arrest. An interim analysis for safety and futility will be performed by an external committee after the first 200 patients have provided endpoint data. Conditional power for meeting the primary endpoint will if needed, be computed at that time, and if the interim results do not correspond to the primary endpoint, termination of the study for futility will be considered. Early stopping for efficacy reasons will only be considered if major outcome differences are seen between the groups according to the Haybittle rule with a p-value ≤0,001.
Intention to treat and per protocol analyses will be performed for all randomized patients. No imputed values will be used for patients for whom data is not available.
Stratified analyses will be performed for patients whose first recorded rhythm is VF/VT versus those in whom the first recorded rhythm is PEA or asystole. Stratification analyses will be performed for subjects where CPR was initiated within 10 minutes by a first responder. Stratified analyses will also be performed for subjects in the treatment group where cooling was started within 15 minutes.
Besides the specific endpoints listed below, substudies will be made to assess the following specific endpoints:
- Prehospital trans-nasal cooling significantly improve the systolic left ventricular function measured as LVEF (performed be Echo).
- Prehospital trans-nasal cooling significantly reduce the infarction size and area at risk and increase the systolic left ventricular function measured as LVEF (ECHO and MRI)in patients with AMI as cause of the cardiac arrest.
- Prehospital trans-nasal cooling significantly reduce in-hospital MACE (Major Adverse Cardiac Events) (i.e. death, reinfarction, stroke, cardiogenic shock, pulmonary oedema, recurrent cardiac arrest and need for.IABP.during hospital stay)
- Prehospital trans-nasal cooling significantly reduces the proportion of patients with cardiogenic shock
- Prehospital trans-nasal cooling significantly reduce days in ventilator, days at ICU and length of stay at hospital among survivors.
- To perform a metaanalysis in regards to ROSC, early and late survival as a pooled analysis of PRINCE data and PRINCESS 200 patientdata.
- Prehospital trans-nasal cooling significantly reduces peak-value of biochemical markers in patients treated with RhinoChill with 25% (measured at 12, 24, 36, 48 and 72 hours).
- To assess the development of end tidal CO2 during resuscitation in patients cooled prehospital wit trans nasal cooling
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- Prehospital intra-nasal cooling with RhinoChill
- Keywords
- Hypothermia, induced, Intra-arrest cooling, Cardiac arrest, Prehospital emergency care, Emergency Medical Services
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypothermia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital intra-nasal cooling with RhinoChillDevice
Patients in the intervention group will receive prehospital intra-nasal cooling with RhinoChill as soon as possible during the resuscitation (i.e. intra-arrest). Intra-nasal cooling will be ongoing until systemic hypothermia is started at the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group standard advanced cardiac life support care. Patients that achieve return of spontaneous circulation will be treated with hypothermia according to current guidelines upon arrival at the intensive care unit. |
| Intervention | Experimental | Intra-arrest trans-nasal cooling with RhinoChill will be initiated during advanced cardiac life support. In patients achieving return of spontaneous circulation, trans-nasal cooling will continue until systemic cooling is started at the intensive care unit. Receives: Device: Prehospital intra-nasal cooling with RhinoChill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologically intact survival (CPC-cerebral performance categories scale 1-2)
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: 90 days after cardiac arrest
Secondary outcomes (4)
Total survival
Measured: 90 days
Proportion of patients achieving Return of Spontaneous Circulation (ROSC).
Measured: 1 hour
Time to target temperature of 32-34º Celsius
Measured: 8-10 hours
Admitted alive to hospital
Proportion of patients that are admitted alive to hospital
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study start6 Jul 2010
- Primary completion31 Jan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital, University Hospital Hradec Kralove, CHU de Charleroi, University Hospital, Lille, Karolinska University Hospital, BeneChill, Inc
- Responsible party
- Principal investigator, Leif Svensson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400373
- Sponsor's protocol ID
- PRINCESS 2010/383-32
- Acronym
- PRINCESS
- Status last verified
- Jun 2018
- First submitted
- 9 Sep 2010
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nordberg P, Taccone FS, Castren M, Truhlar A, Desruelles D, Forsberg S, Hollenberg J, Vincent JL, Svensoon L. Design of the PRINCESS trial: pre-hospital resuscitation intra-nasal cooling effectiveness survival study (PRINCESS). BMC Emerg Med. 2013 Nov 25;13:21. doi: 10.1186/1471-227X-13-21.
PubMed 24274342Castren 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 20679548Nordberg P, Taccone FS, Truhlar A, Forsberg S, Hollenberg J, Jonsson M, Cuny J, Goldstein P, Vermeersch N, Higuet A, Jimenes FC, Ortiz FR, Williams J, Desruelles D, Creteur J, Dillenbeck E, Busche C, Busch HJ, Ringh M, Konrad D, Peterson J, Vincent JL, Svensson L. Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest: The PRINCESS Randomized Clinical Trial. JAMA. 2019 May 7;321(17):1677-1685. doi: 10.1001/jama.2019.4149.
PubMed 31063573
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
- ClinicalTrials.gov ID
- NCT01400373
- Acronym / sponsor ID
- PRINCESS / PRINCESS 2010/383-32
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- Hypothermia, induced, Intra-arrest cooling, Cardiac arrest, Prehospital emergency care, Emergency Medical Services
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Erasme University Hospital, University Hospital Hradec Kralove, CHU de Charleroi, University Hospital, Lille, Karolinska University Hospital, BeneChill, Inc
- Study start
- 6 Jul 2010 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010.
The main purpose of this study is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.
Detailed description
Background:
The RhinoChill Device is a non-invasive, portable cooling device through which rapid cooling is achieved via the trans-nasal delivery of an evaporative coolant into the nasopharynx. Animal studies suggest a life-saving benefit for intra-arrest cooling.
Results from a European multicenter randomized trial (PRINCE - Pre Rosc Intra Nasal Cooling Effectiveness), published in Circulation in August 2010, demonstrate that intra-arrest trans-nasal evaporative cooling can be used safely and effectively in prehospital cardiac arrest without interfering with advanced cardiac life support protocols.
The outcome results among patients admitted to hospital showed a trend towards improved survival to hospital discharge in the treatment group (43.8% versus 31.0, p=0.26). The difference in neurologically intact survival was 34.4% vs 21.4%). In the subgroup of patients where cardiopulmonary resuscitation (CPR) was started by Emergency Medical Services personnel within 10 minutes (78 % of total number of patients) the difference in total survival between the groups was (56.5 versus 29.4, p=0.03). Neurologically intact survival for the corresponding subgroup was 43.5% vs 17.6%. In the treatment group, time to tympanic temperature of 34º was reached 3 hours faster (102 min versus 291 min, p=0.03) and time to core temperature 2 hours faster (155 min versus 284 min, p=0.13).
This study is powered to detect clinically significant changes in neurologically intact survival at 90 days after cardiac arrest. An interim analysis for safety and futility will be performed by an external committee after the first 200 patients have provided endpoint data. Conditional power for meeting the primary endpoint will if needed, be computed at that time, and if the interim results do not correspond to the primary endpoint, termination of the study for futility will be considered. Early stopping for efficacy reasons will only be considered if major outcome differences are seen between the groups according to the Haybittle rule with a p-value ≤0,001.
Intention to treat and per protocol analyses will be performed for all randomized patients. No imputed values will be used for patients for whom data is not available.
Stratified analyses will be performed for patients whose first recorded rhythm is VF/VT versus those in whom the first recorded rhythm is PEA or asystole. Stratification analyses will be performed for subjects where CPR was initiated within 10 minutes by a first responder. Stratified analyses will also be performed for subjects in the treatment group where cooling was started within 15 minutes.
Besides the specific endpoints listed below, substudies will be made to assess the following specific endpoints:
- Prehospital trans-nasal cooling significantly improve the systolic left ventricular function measured as LVEF (performed be Echo).
- Prehospital trans-nasal cooling significantly reduce the infarction size and area at risk and increase the systolic left ventricular function measured as LVEF (ECHO and MRI)in patients with AMI as cause of the cardiac arrest.
- Prehospital trans-nasal cooling significantly reduce in-hospital MACE (Major Adverse Cardiac Events) (i.e. death, reinfarction, stroke, cardiogenic shock, pulmonary oedema, recurrent cardiac arrest and need for.IABP.during hospital stay)
- Prehospital trans-nasal cooling significantly reduces the proportion of patients with cardiogenic shock
- Prehospital trans-nasal cooling significantly reduce days in ventilator, days at ICU and length of stay at hospital among survivors.
- To perform a metaanalysis in regards to ROSC, early and late survival as a pooled analysis of PRINCE data and PRINCESS 200 patientdata.
- Prehospital trans-nasal cooling significantly reduces peak-value of biochemical markers in patients treated with RhinoChill with 25% (measured at 12, 24, 36, 48 and 72 hours).
- To assess the development of end tidal CO2 during resuscitation in patients cooled prehospital wit trans nasal cooling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group standard advanced cardiac life support care. Patients that achieve return of spontaneous circulation will be treated with hypothermia according to current guidelines upon arrival at the intensive care unit. |
| Intervention | Experimental | Device: Prehospital intra-nasal cooling with RhinoChillIntra-arrest trans-nasal cooling with RhinoChill will be initiated during advanced cardiac life support. In patients achieving return of spontaneous circulation, trans-nasal cooling will continue until systemic cooling is started at the intensive care unit. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Collapse was witnessed (heard or seen)
- Do not have a pulse
- Are unresponsive to external stimuli
Key exclusion criteria (11 listed)
- Age ≥80 years
- Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose, cerebrovascular accident, drowning, smoke inhalation, electrocution, hanging
- Already hypothermic (e.g., avalanche victim; found in the snow)
- Have an obvious barrier to placing intra nasal catheters (e.g., intranasal obstruction)
- 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 |
|---|---|---|
| Prehospital intra-nasal cooling with RhinoChillPatients in the intervention group will receive prehospital intra-nasal cooling with RhinoChill as soon as possible during the resuscitation (i.e. intra-arrest). Intra-nasal cooling will be ongoing until systemic hypothermia is started at the intensive care unit. | Device | Intervention |
Primary outcome
Neurologically intact survival (CPC-cerebral performance categories scale 1-2)
Time frame: 90 days after cardiac 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
4 secondary outcomes
Total survival
Time frame: 90 days
Proportion of patients achieving Return of Spontaneous Circulation (ROSC).
Time frame: 1 hour
Time to target temperature of 32-34º Celsius
Time frame: 8-10 hours
Admitted alive to hospital
Time frame: 2-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 24274342Nordberg P, Taccone FS, Castren M, Truhlar A, Desruelles D, Forsberg S, Hollenberg J, Vincent JL, Svensoon L. Design of the PRINCESS trial: pre-hospital resuscitation intra-nasal cooling effectiveness survival study (PRINCESS). BMC Emerg Med. 2013 Nov 25;13:21. doi: 10.1186/1471-227X-13-21.
- Background: 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.
- Derived from this study: PubMed 31063573Nordberg P, Taccone FS, Truhlar A, Forsberg S, Hollenberg J, Jonsson M, Cuny J, Goldstein P, Vermeersch N, Higuet A, Jimenes FC, Ortiz FR, Williams J, Desruelles D, Creteur J, Dillenbeck E, Busche C, Busch HJ, Ringh M, Konrad D, Peterson J, Vincent JL, Svensson L. Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest: The PRINCESS Randomized Clinical Trial. JAMA. 2019 May 7;321(17):1677-1685. doi: 10.1001/jama.2019.4149.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prehospital intra-nasal cooling with RhinoChill in people with Out-of-hospital Cardiac Arrest, run by Karolinska Institutet at 2 sites in 2 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 11 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurologically intact survival (CPC-cerebral performance categories scale 1-2) (time frame: 90 days after cardiac arrest). 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 NCT01400373, which also lists 3 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 29 Jun 2018.