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Core Temperature in Patients With OHCA (CT-OCHA)

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ClinicalTrials.gov Identifier: NCT04976712
Recruitment Status : Not yet recruiting
First Posted : July 26, 2021
Last Update Posted : July 26, 2021
Sponsor:
Collaborator:
Institute of Mountain Emergency Medicine
Information provided by (Responsible Party):
Elisabeth Gruber, Azienda Sanitaria dell'Alto Adige

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.

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

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;

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Study Type : Observational
Estimated Enrollment : 256 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Core Temperature in Patients With Out of Hospital Cardiac Arrest in South Tyrol - a Prospective Observational Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Core temperature at hospital arrival [ Time Frame: through study completion, an average of 1 year ]
    ° Celsius


Secondary Outcome Measures :
  1. Core temperature at ROSC [ Time Frame: through study completion, an average of 1 year ]
    ° Celsius

  2. Environmental temperature on scene [ Time Frame: through study completion, an average of 1 year ]
    ° Celsius

  3. Time of resuscitation from OHCA to ROSC [ Time Frame: through study completion, an average of 1 year ]
    minutes

  4. OHCA rhythm at arrival of ALS team [ Time Frame: through study completion, an average of 1 year ]
    ECG rhythm: asystolia, PEA, ventricular fibrillation, ventricular tachicardia

  5. Use of mechanical chest compression device on prehospital intervention [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with out of hospital cardiac arrest transferred to hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976712


Contacts
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Contact: Rosmarie Oberhammer, MD 00399474581660 rosmarie.oberhammer@sabes.it

Locations
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Italy
Bruneck Regional Hospital
Bruneck, Italy, 39031
Sponsors and Collaborators
Azienda Sanitaria dell'Alto Adige
Institute of Mountain Emergency Medicine
Investigators
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Study Director: Rosmarie Oberhammer, MD Azienda Sanitaria dell'Alto Adige
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Responsible Party: Elisabeth Gruber, Principal Investigator, Azienda Sanitaria dell'Alto Adige
ClinicalTrials.gov Identifier: NCT04976712    
Other Study ID Numbers: BZ-107-2020
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabeth Gruber, Azienda Sanitaria dell'Alto Adige:
Out-Of-Hospital Cardiac Arrest
Accidental Hypothermia
Core Temperature
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Hypothermia
Body Temperature Changes
Heart Diseases
Cardiovascular Diseases