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Clinical Trials/NCT04935632
NCT04935632
Completed
Not Applicable

Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)

Centre Leon Berard1 site in 1 country388 target enrollmentJune 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypothermia
Sponsor
Centre Leon Berard
Enrollment
388
Locations
1
Primary Endpoint
Incidence of intraoperative hypothermia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.

Registry
clinicaltrials.gov
Start Date
June 21, 2021
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \>= 18 years old
  • surgeries performed at the Centre Léon Bérard

Exclusion Criteria

  • Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
  • Patient who decline to participate in the study
  • Active systemic infection
  • Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
  • Deprivation of liberty
  • operation performed under local anesthesia only

Outcomes

Primary Outcomes

Incidence of intraoperative hypothermia

Time Frame: Up to 24 hours

From the time of entry into the operating room to the time of exit from the operating room. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

Secondary Outcomes

  • Intraoperative tympanic temperature(Up to 24 hours)
  • Incidence of hypothermia in the post-anesthesia care unit (PACU)(Up to 24 hours)
  • Tympanic temperature in the post-anaesthesia care unit (PACU)(Up to 24 hours)

Study Sites (1)

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