- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790086
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes (HYPOTHERMIE)
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery
The primary objectives of the study are
- to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
- to assess the impact of perioperative hypothermia on anemia and myocardial injury.
Study Overview
Status
Conditions
Detailed Description
100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks.
The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pascal ALFONSI, MD
- Phone Number: + 33 1 58 41 41 41
- Email: pascal.alfonsi@apr.aphp.fr
Study Contact Backup
- Name: Philippe ARGERTER, MD, PhD
- Phone Number: + 33 1 49 09 58 86
- Email: philippe.aegerter@apr.aphp.fr
Study Locations
-
-
Ile de France
-
Paris, Ile de France, France, 75014
- Recruiting
- Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin
-
Contact:
- Pascal ALFONSI, MD
- Phone Number: + 33 1 58 41 41 41
- Email: pascal.alfonsi@apr.aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Non-ambulatory surgery.
- Duration of anesthesia > 30 minutes.
- Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery.
- Type of anesthesia: general, intrathecal or epidural anesthesia.
- patient ≥ 45 years.
- No opposition of patient to participate in the study.
Exclusion criteria:
- Emergency surgery.
- Cardiac surgery, proctology surgery or thoracic surgery.
- Digestive endoscopy or surgical radiology.
- Septic surgery.
- Patient with at least one organ failure.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core temperature
Time Frame: up to 24 hours
|
The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France).
|
up to 24 hours
|
blood loss
Time Frame: up to 24 hours
|
Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.
|
up to 24 hours
|
myocardial injury
Time Frame: up to 48 hours
|
Troponin T will be measured after the surgical intervention (at least 6 hours after the end of the surgery) and on the second postoperative day (when the patient remains hospitalized).
|
up to 48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pascal ALFONSI, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-HYPOTHERMIE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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