Core Temperature in Patients With OHCA

Recruiting

• Conditions: Accidental Hypothermia; Temperature Change, Body; Out-Of-Hospital Cardiac Arrest

• Registration Number: NCT04976712
• Lead Sponsor: Azienda Sanitaria dell'Alto Adige

Brief Summary

A prospective observational study aiming to monitor core temperature via an esophageal probe in out of hospital cardiac arrest during transport and until arrival in hospital. Insertion of an esophageal temperature probe will be done on scene during ongoing resuscitation manoeuvres based on European Resuscitation Council Guidelines 2015 (or newer). Environmental temperature influence and hypothermia prevention interventions will be monitored.

Detailed Description

Prospective observational study to evaluate the body temperature difference in patients in out of hospital cardiac arrest on site and at arrival at the hospital.

If the patient fulfills the inclusion criteria and after establishment of CPR measures according the ERC resuscitation guidelines (2015 or newer) an esophageal probe will be inserted and bodytemperature is measured; on site ambiental temperature will also be measured. Weather conditions, altitude on site, activity of the patient and hypothermia protection (eg. clothes) will bei documented. On arrival in hospital the body temperature will be measured with the esophageal probe;

Study Timeline

• Study First Submitted: 2021-06-23
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-20
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Out of hospital cardiac arrest
• Patients transferred to hospital
• > 18 years

Exclusion Criteria

• Obvious signs of death
• Obvious lethal injury/injuries incompatible with life
• Confirmation of death on scene
• < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Core temperature at hospital arrival	through study completion, an average of 1 year	° Celsius

Secondary Outcome Measures

Name	Time	Method
Core temperature at ROSC	through study completion, an average of 1 year	° Celsius
Time of resuscitation from OHCA to ROSC	through study completion, an average of 1 year	minutes
Use of mechanical chest compression device on prehospital intervention	through study completion, an average of 1 year
Environmental temperature on scene	through study completion, an average of 1 year	° Celsius
OHCA rhythm at arrival of ALS team	through study completion, an average of 1 year	ECG rhythm: asystolia, PEA, ventricular fibrillation, ventricular tachicardia

Trial Locations

Locations (1)

Bruneck Regional Hospital; 🇮🇹 Bruneck, Italy