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Recruiting NCT04976712

Core Temperature in Patients With OHCA

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Out-Of-Hospital Cardiac Arrest, Accidental Hypothermia, Temperature Change, Body. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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;

Primary outcome measures

  • Core temperature at hospital arrival [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Bruneck Regional Hospital — Bruneck

Identifiers

NCT: NCT04976712 · BZ-107-2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗