Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study (PRINCESS)
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|ClinicalTrials.gov Identifier: NCT01400373|
Recruitment Status : Recruiting
First Posted : July 22, 2011
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Out-of-hospital Cardiac Arrest||Device: Prehospital intra-nasal cooling with RhinoChill||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
No Intervention: Control
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.
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.
Device: Prehospital intra-nasal cooling with RhinoChill
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.
- 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."
- - 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
- 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 ]Proportion of patients that are admitted alive to hospital
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400373
|Contact: Leif Svensson, MD, PhD||+46 8 616 10 email@example.com|
|Contact: Per Nordberg, MD, PhD||+46 8 616 35 firstname.lastname@example.org|
|Department of Intensive Care, Erasme University Hospital||Recruiting|
|Contact: Fabio Taccone, MD +322 555 5587 email@example.com|
|Department of Cardiology, Karolinska Institutet, Södersjukhuset||Recruiting|
|Stockholm, Sweden, 11883|
|Contact: Leif Svensson, MD. PhD +46 8 616 19 18 firstname.lastname@example.org|
|Contact: Per Nordberg, MD. PhD. + 46 8 616 35 83 email@example.com|
|Principal Investigator: Leif Svensson, MD. PhD|
|Principal Investigator: Per Nordberg, MD. PhD|