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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02790086

Acronym

HYPOTHERMIE

Enrollment

2000

Registered

2016-06-03

Start date

2014-10-31

Completion date

2016-10-31

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Perioperative

Keywords

hypothermia, prevalence, perioperative, anemia, myocardial injury, troponin T, noncardiac surgery

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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Core temperature	up to 24 hours	The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France).
blood loss	up to 24 hours	Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.
myocardial injury	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).

Countries

France

Contacts

Primary ContactPascal ALFONSI, MD

pascal.alfonsi@apr.aphp.fr+ 33 1 58 41 41 41

Backup ContactPhilippe ARGERTER, MD, PhD

philippe.aegerter@apr.aphp.fr+ 33 1 49 09 58 86

Outcome results