Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study

NCT01400373 | Completed Phase 2

• 1 other identifier: PRINCESS 2010/383-32
• Study Type: interventional
• Target: 700
• Locations: 2 countries
• Sites: 2

Brief 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 at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.

Conditions

Out-of-hospital Cardiac Arrest

Keywords

Hypothermia, induced; Intra-arrest cooling; Cardiac arrest; Prehospital emergency care; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• 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." 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

  90 days after cardiac arrest

Secondary Outcomes (4)

• Total survival

  90 days

• Proportion of patients achieving Return of Spontaneous Circulation (ROSC).

  1 hour

• Time to target temperature of 32-34º Celsius

  8-10 hours

• Admitted alive to hospital

  2-4 hours

Study Arms (2)

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.

Device: Prehospital intra-nasal cooling with RhinoChill

Interventions

Prehospital intra-nasal cooling with RhinoChill DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Collapse was witnessed (heard or seen)
• Do not have a pulse
• Are unresponsive to external stimuli

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Erasme University Hospital: collaborator
• University Hospital Hradec Kralove: collaborator
• CHU de Charleroi: collaborator
• University Hospital, Lille: collaborator
• Karolinska University Hospital: collaborator
• BeneChill, Inc: collaborator

Study Sites (2)

Department of Intensive Care, Erasme University Hospital

Brussels, Belgium

Location

Department of Cardiology, Karolinska Institutet, Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (3)

• 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.

  PMID: 24274342 BACKGROUND

• Castren 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.

  PMID: 20679548 BACKGROUND

• Nordberg 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.

  PMID: 31063573 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Hypothermia; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leif Svensson, MD, PhD. Associate Professor in Cardiology. Karolinska Institutet, Södersjukhuset.

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: July 22, 2011
• Study Start: July 6, 2010
• Primary Completion: January 31, 2018
• Study Completion: April 30, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

BE (1); SE (1)