Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes (HYPOTHERMIE)
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|ClinicalTrials.gov Identifier: NCT02790086|
Recruitment Status : Unknown
Verified May 2016 by Société Française d'Anesthésie et de Réanimation.
Recruitment status was: Recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
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.
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||October 2016|
- 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).
- blood loss [ Time Frame: up to 24 hours ]Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.
- 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).
Biospecimen Retention: Samples Without DNA
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): NCT02790086
|Contact: Pascal ALFONSI, MD||+ 33 1 58 41 41 email@example.com|
|Contact: Philippe ARGERTER, MD, PhD||+ 33 1 49 09 58 firstname.lastname@example.org|
|Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin||Recruiting|
|Paris, Ile de France, France, 75014|
|Contact: Pascal ALFONSI, MD + 33 1 58 41 41 41 email@example.com|
|Principal Investigator:||Pascal ALFONSI, MD||Assistance Publique - Hôpitaux de Paris|