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

NCT ID: NCT02790086

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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).

Conditions

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Hypothermia, Perioperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal ALFONSI, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pascal ALFONSI, MD

Role: CONTACT

+ 33 1 58 41 41 41

Philippe ARGERTER, MD, PhD

Role: CONTACT

+ 33 1 49 09 58 86

Facility Contacts

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Pascal ALFONSI, MD

Role: primary

+ 33 1 58 41 41 41

Other Identifiers

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13-HYPOTHERMIE

Identifier Type: -

Identifier Source: org_study_id

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