Core Temperature in Patients With OHCA

Out-Of-Hospital Cardiac Arrest Clinical Trial

— CT-OCHA  

Official title:

Core Temperature in Patients With Out of Hospital Cardiac Arrest in South Tyrol - a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04976712
• Other study ID #: BZ-107-2020
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2022
• Source: Azienda Sanitaria dell'Alto Adige
• Contact: Rosmarie Oberhammer, MD
• Phone: 00399474581660
• Email: rosmarie.oberhammer[@]sabes.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Hypothermia
• Body Temperature Changes
• Heart Arrest
• Hypothermia
• Out-of-Hospital Cardiac Arrest
• Temperature Change, Body

Locations

Country	Name	City	State
Italy	Bruneck Regional Hospital	Bruneck

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Sanitaria dell'Alto Adige	Institute of Mountain Emergency Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature at hospital arrival	° Celsius	through study completion, an average of 1 year
Secondary	Core temperature at ROSC	° Celsius	through study completion, an average of 1 year
Secondary	Environmental temperature on scene	° Celsius	through study completion, an average of 1 year
Secondary	Time of resuscitation from OHCA to ROSC	minutes	through study completion, an average of 1 year
Secondary	OHCA rhythm at arrival of ALS team	ECG rhythm: asystolia, PEA, ventricular fibrillation, ventricular tachicardia	through study completion, an average of 1 year
Secondary	Use of mechanical chest compression device on prehospital intervention		through study completion, an average of 1 year