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Tests treatment safety and results for Out-Of-Hospital Cardiac Arrest
Official title Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
ClinicalTrials.gov ID: NCT06025123
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Patients ≥18 years that meet all of the following
- Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
- Unconsciousness defined as Glasgow Coma Scale \< 8
- Inclusion within 20 minutes from EMS arrival
You likely can't join if
- Patients are not eligible if they meet one or more of the following criteria:
- Age ≥ 80 years
- Obvious non-cardiac causes to cardiac arrest
- Obvious already hypothermic
- Obvious barrier to placing intra nasal catheters
- Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
See the full eligibility criteria
- Patients ≥18 years that meet all of the following
- Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
- Unconsciousness defined as Glasgow Coma Scale \< 8
- Inclusion within 20 minutes from EMS arrival
- Patients are not eligible if they meet one or more of the following criteria:
- Age ≥ 80 years
- Obvious non-cardiac causes to cardiac arrest
- Obvious already hypothermic
- Obvious barrier to placing intra nasal catheters
- Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
- Have a known terminal disease
- Known or clinically apparent pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Brussels, Belgium
- Freiburg im Breisgau, Germany
- Milan, Italy
- Ljubljana, Slovenia
- Madrid, Spain
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Brussels, Belgium; Freiburg im Breisgau, Germany; Milan, Italy; Ljubljana, Slovenia; Madrid, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.