Core Temperature in Patients With OHCA (CT-OCHA)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 256

Contacts and Locations

• Study Contact: Name: Rosmarie Oberhammer, MD; Phone Number: 00399474581660; Email: rosmarie.oberhammer@sabes.it

Study Locations

• Italy
  • Bruneck, Italy, 39031
    • Recruiting
    • Bruneck Regional Hospital
    • Contact: Rosmarie Oberhammer, MD; Phone Number: 00390474581660; Email: rosmarie.oberhammer@icloud.com
    • Contact: Elisabeth Gruber, MD; Phone Number: 00390474581660; Email: elisabeth.gruber@sabes.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with out of hospital cardiac arrest transferred to hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core temperature at hospital arrival	° Celsius	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria dell'Alto Adige
• Collaborators: Institute of Mountain Emergency Medicine
• Investigators: Study Director: Rosmarie Oberhammer, MD, Azienda Sanitaria dell'Alto Adige

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): September 30, 2026
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Out-Of-Hospital Cardiac Arrest; Core Temperature; Accidental Hypothermia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Hypothermia; Out-of-Hospital Cardiac Arrest; Body Temperature Changes
• Other Study ID Numbers: BZ-107-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No