Core Temperature in Patients With OHCA | NCT04976712

Studies
Core Temperature in Patients With OHCA

NCT04976712

Sponsor

Azienda Sanitaria dell'Alto Adige

Status

Recruiting

Last Update Posted

Dec 20, 2022Actual

Enrollment

256Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Jun 23, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2022

Last Update Posted Date

Dec 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elisabeth Gruber, Principal Investigator, Azienda Sanitaria dell'Alto AdigePrincipal Investigator

Lead Sponsor

Azienda Sanitaria dell'Alto AdigeOTHER

Collaborators

Name	Class
Institute of Mountain Emergency Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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;

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

256Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with out of hospital cardiac arrest transferred to hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rosmarie Oberhammer, MD	Contact	00399474581660		rosmarie.oberhammer@sabes.it

Overall Officials

Name	Affiliation	Role
Rosmarie Oberhammer, MD	Azienda Sanitaria dell'Alto Adige	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bruneck Regional Hospital	Recruiting	Bruneck		39031	Italy

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest
D007035	Hypothermia
D001832	Body Temperature Changes

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided