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

Hypothermia, Perioperative Clinical Trial

— HYPOTHERMIE  

Official title:

Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02790086
• Other study ID #: 13-HYPOTHERMIE
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2016
• Last updated: June 2, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Société Française d'Anesthésie et de Réanimation
• Contact: Pascal ALFONSI, MD
• Phone: + 33 1 58 41 41 41
• Email: pascal.alfonsi[@]apr.aphp.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Perioperative

Locations

Country	Name	City	State
France	Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature	The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France).	up to 24 hours	No
Primary	blood loss	Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.	up to 24 hours	No
Primary	myocardial injury	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	No