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RecruitingNCT04976712CT-OCHAUpdated Aug 11, 2026

Core Temperature in Patients With OHCA

An observational study in Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia and Temperature Change, Body, sponsored by Azienda Sanitaria dell'Alto Adige. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Azienda Sanitaria dell'Alto Adige · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
256
Ages
18 Years and older
Sex
All
01

Study 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.

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;

02

Conditions studied

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

Keywords

  • Out-Of-Hospital Cardiac Arrest
  • Accidental Hypothermia
  • Core Temperature
03

In context

Out-of-Hospital Cardiac Arrest

314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.

This study's planned enrollment of 256 is below the median of 300 across 128 observational studies indexed under Out-of-Hospital Cardiac Arrest.

Browse Out-of-Hospital Cardiac Arrest studies →

Lead sponsor

Azienda Sanitaria dell'Alto Adige is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with out of hospital cardiac arrest transferred to hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Obvious signs of death
  • Obvious lethal injury/injuries incompatible with life
  • Confirmation of death on scene
  • \< 18 years
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
256 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Core temperature at hospital arrival

    ° Celsius

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Core temperature at ROSC

    ° Celsius

    Time frame: through study completion, an average of 1 year

  2. Environmental temperature on scene

    ° Celsius

    Time frame: through study completion, an average of 1 year

  3. Time of resuscitation from OHCA to ROSC

    minutes

    Time frame: through study completion, an average of 1 year

  4. OHCA rhythm at arrival of ALS team

    ECG rhythm: asystolia, PEA, ventricular fibrillation, ventricular tachicardia

    Time frame: through study completion, an average of 1 year

  5. Use of mechanical chest compression device on prehospital intervention

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Sep 2027, 74 months after the start.

Of 69 non-industry observational studies under Out-of-Hospital Cardiac Arrest, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 75. This study's planned 74 months is above that.

Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 20 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2021
First posted
Jul 26, 2021
StartActual
Jul 1, 2021
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04976712
Lead sponsor
Azienda Sanitaria dell'Alto Adige
Collaborators
Institute of Mountain Emergency Medicine
Responsible party
Elisabeth Gruber (Principal Investigator, Azienda Sanitaria dell'Alto Adige) — Principal investigator
First posted
Jul 26, 2021
Start date
Jul 1, 2021
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Rosmarie Oberhammer, MD
Contact
rosmarie.oberhammer@sabes.it
00399474581660
Rosmarie Oberhammer, MD
study director · Azienda Sanitaria dell'Alto Adige

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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