Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Hypothermia Clinical Trial

— PRINCESS2  

Official title:

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025123
• Other study ID #: 2022-02446-01
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: May 2028

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Per Nordberg, MD, PhD
• Phone: +46702802579
• Email: per.nordberg[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm.

The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia.

Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1022
• Est. completion date: May 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

INCLUSION CRITERIA:

Patients =18 years that meet all of the following inclusion criteria:

1. Adult out-of-hospital cardiac arrest patients with initial shockable rhythm

2. Unconsciousness defined as Glasgow Coma Scale < 8

3. Inclusion within 20 minutes from EMS arrival

EXCLUSION CRITERIA:

Patients are not eligible if they meet one or more of the following criteria:

1. Age = 80 years

2. Obvious non-cardiac causes to cardiac arrest

3. Obvious already hypothermic

4. Obvious barrier to placing intra nasal catheters

5. Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care

6. Have a known terminal disease

7. Known or clinically apparent pregnancy

Related Conditions & MeSH terms

• Hypothermia
• Out-Of-Hospital Cardiac Arrest
• Ventricular Fibrillation

Intervention

Device:
• Early transnasal evaporative cooling with the RhinoChill device
Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours

Locations

Country	Name	City	State
Austria	University Hospital Vienna	Vienna
Belgium	Erasme University Hospital	Brussels
Germany	University Hospital Freiburg	Freiburg
Italy	Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Slovenia	Ljubljana University Medical Centre	Ljubljana
Spain	Hospital Universitario La Paz	Madrid
Sweden	Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy,  Slovenia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital-free days alive at 90 days		Day 90
Other	Distribution of modified Rankin scale at 90 days	The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.	Day 90
Other	Distribution of Cerebral Performance Category scale at 90 days	The Cerebral Performance Category (CPC) scale is a measure for neurologic function. It ranges from 1-5, where 1 equals no or minimal neurologic disabilities, and 5 equals death.	Day 90
Other	Proportion of patients alive after 1 year		Day 365
Other	Proportion of patients with Modified Rankin scale 0-1 at 1 year	The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.	Day 365
Other	Quality of life assessed with EQ-5D-5L at 90 days	EQ-5D is a a measure of health status and quality of life defined in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels; no problems, some or moderate problems or extreme problems.	Day 90
Primary	Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.	The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.	Day 90
Secondary	Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital		Day 1
Secondary	Proportion of patients alive at hospital discharge		Day 1-90
Secondary	Proportion of patients with Modified Rankin scale 0-3 at hospital discharge	The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.	Day 1-90
Secondary	Proportion of patients alive at 90 days		Day 90
Secondary	Proportion of patients with Modified Rankin scale 0-3 at 90 days	The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.	Day 90
Secondary	Device related adverse event rate within the first 24 hours	Safety	Day 1
Secondary	Composite serious adverse event rate within the first 7 days	Safety	Day 1-7
Secondary	Proportion of patients with new cardiac arrest prior to hospital admission	Safety	Day 1