Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes (HYPOTHERMIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Société Française d'Anesthésie et de Réanimation

Brief Summary:

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
Hypothermia, Perioperative

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia




Primary Outcome Measures :
  1. 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).

  2. blood loss [ Time Frame: up to 24 hours ]
    Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.

  3. 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
2 tubes of 5 ml of blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing surgical intervention, requiring 2 days of hospitalization
Criteria

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.

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): NCT02790086


Contacts
Layout table for location contacts
Contact: Pascal ALFONSI, MD + 33 1 58 41 41 41 pascal.alfonsi@apr.aphp.fr
Contact: Philippe ARGERTER, MD, PhD + 33 1 49 09 58 86 philippe.aegerter@apr.aphp.fr

Locations
Layout table for location information
France
Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin Recruiting
Paris, Ile de France, France, 75014
Contact: Pascal ALFONSI, MD    + 33 1 58 41 41 41    pascal.alfonsi@apr.aphp.fr   
Sponsors and Collaborators
Société Française d'Anesthésie et de Réanimation
Investigators
Layout table for investigator information
Principal Investigator: Pascal ALFONSI, MD Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Société Française d'Anesthésie et de Réanimation
ClinicalTrials.gov Identifier: NCT02790086    
Other Study ID Numbers: 13-HYPOTHERMIE
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Société Française d'Anesthésie et de Réanimation:
hypothermia
prevalence
perioperative
anemia
myocardial injury
troponin T
noncardiac surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypothermia
Body Temperature Changes