PRINCESS
Research type
Research Study
Full title
Prehospital Resuscitation IntraNasal Cooling Effectiveness Survival Study (PRINCESS)
IRAS ID
156397
Contact name
Richard Lyon
Contact email
Sponsor organisation
Karolinska Institute
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Ethical Review, PRINCESS 2010/383-82
Duration of Study in the UK
1 years, 10 months, 12 days
Research summary
Out-of-hospital cardiac arrest (OHCA) is a leading cause of death and severe neurological disability. Pre-hospital care aims to achieve rapid recovery and preserve both heart and brain function. Patients who fail to
achieve return of spontaneous circulation (ROSC) during the pre-hospital phase of resuscitation rarely survive.
Therapeutic hypothermia (targeted temperature management) can improve outcome from OHCA in selected patients. Recent animal and human studies have shown therapeutic hypothermia should be initiated as early as possible following cardiac arrest.
Intra-nasal, evaporative cooling presents a novel, rapid means of directly cooling the brain in the pre-hospital environment in order to preserve neurological function.
Pre-hospital, intra-nasal evaporative cooling during cardiac arrest has not yet been trialled in the United Kingdom. This intervention for OHCA has the potential to save lives and improve patients' outcomes from OHCA and one way of achieving this intervention is through use of the Rhinochill device.
By joining the existing international trial (PRINCESS), which is currently in progress in four other countries, the UK will make a significant contribution to proving whether pre-hospital, intranasal cooling during cardiac arrest with the Rhinochill device can improve outcomes from OHCA.
The results of this study will potentially have significant impact on how OHCA patients are managed in the pre-hospital environment.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1764
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion