Out-Of-Hospital Cardiac ArrestCT-OCHANCT04976712
Core Temperature in Patients With OHCA
An observational study of Out-Of-Hospital Cardiac Arrest and Accidental Hypothermia, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia, Temperature Change, Body
- How many people
- 256 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with out of hospital cardiac arrest transferred to hospital
Who may be able to join
- Out of hospital cardiac arrest
- Patients transferred to hospital
- > 18 years
Who cannot join
- Obvious signs of death
- Obvious lethal injury/injuries incompatible with life
- Confirmation of death on scene
- < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Bruneck Regional Hospital
Bruneck, 39031
Rosmarie Oberhammer, MD, 00390474581660, rosmarie.oberhammer@icloud.com
Elisabeth Gruber, MD, 00390474581660, elisabeth.gruber@sabes.it
About this study
Official title: 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.
Read the 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;
- Keywords
- Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia, Core Temperature
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hypothermia, Body Temperature Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature at hospital arrival
° Celsius
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Core temperature at ROSC
° Celsius
Measured: through study completion, an average of 1 year
Environmental temperature on scene
° Celsius
Measured: through study completion, an average of 1 year
Time of resuscitation from OHCA to ROSC
minutes
Measured: through study completion, an average of 1 year
OHCA rhythm at arrival of ALS team
ECG rhythm: asystolia, PEA, ventricular fibrillation, ventricular tachicardia
Measured: through study completion, an average of 1 year
Use of mechanical chest compression device on prehospital intervention
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria dell'Alto Adige
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Responsible party
- Principal investigator, Elisabeth Gruber, Azienda Sanitaria dell'Alto Adige
- Investigators
- Rosmarie Oberhammer, MD, Study director, Azienda Sanitaria dell'Alto Adige
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976712
- Sponsor's protocol ID
- BZ-107-2020
- Acronym
- CT-OCHA
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Temperature in Patients With Out of Hospital Cardiac Arrest in South Tyrol - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04976712
- Acronym / sponsor ID
- CT-OCHA / BZ-107-2020
- Keywords
- Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia, Core Temperature
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Azienda Sanitaria dell'Alto AdigeUniversity, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with out of hospital cardiac arrest transferred to hospital
Key inclusion criteria (3 listed)
- Out of hospital cardiac arrest
- Patients transferred to hospital
- > 18 years
Key exclusion criteria (4 listed)
- Obvious signs of death
- Obvious lethal injury/injuries incompatible with life
- Confirmation of death on scene
- < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Core temperature at hospital arrival
Time frame: through study completion, an average of 1 year
° Celsius
5 secondary outcomes
Core temperature at ROSC
Time frame: through study completion, an average of 1 year
Environmental temperature on scene
Time frame: through study completion, an average of 1 year
Time of resuscitation from OHCA to ROSC
Time frame: through study completion, an average of 1 year
OHCA rhythm at arrival of ALS team
Time frame: through study completion, an average of 1 year
Use of mechanical chest compression device on prehospital intervention
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosmarie Oberhammer, MD study director
Azienda Sanitaria dell'Alto Adige
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Accidental Hypothermia, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosmarie Oberhammer, MD (00399474581660, rosmarie.oberhammer@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature at hospital arrival (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.