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

Unknown

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

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ile de France
      • Paris, Ile de France, France, 75014
        • Recruiting
        • Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing surgical intervention, requiring 2 days of hospitalization

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pascal ALFONSI, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-HYPOTHERMIE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Hypothermia, Perioperative

3
Subscribe