NCT04976712

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2021Sep 2026

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

5.3 years

First QC Date

June 23, 2021

Last Update Submit

December 16, 2022

Conditions

Out-Of-Hospital Cardiac ArrestAccidental HypothermiaTemperature Change, Body

Keywords

Out-Of-Hospital Cardiac ArrestAccidental HypothermiaCore Temperature

Outcome Measures

Primary Outcomes (1)

  • Core temperature at hospital arrival

    ° Celsius

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • Core temperature at ROSC

    through study completion, an average of 1 year

  • Environmental temperature on scene

    through study completion, an average of 1 year

  • Time of resuscitation from OHCA to ROSC

    through study completion, an average of 1 year

  • OHCA rhythm at arrival of ALS team

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with out of hospital cardiac arrest transferred to hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruneck Regional Hospital

Bruneck, 39031, Italy

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHypothermiaBody Temperature Changes

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rosmarie Oberhammer, MD

    Azienda Sanitaria dell'Alto Adige

    STUDY DIRECTOR

Central Study Contacts

Rosmarie Oberhammer, MD

CONTACT

00399474581660rosmarie.oberhammer@sabes.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 26, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

IT(1)