Perioperative Collection of Temperatures and Hypothermia

Completed

• Conditions: Hypothermia; Anesthesia; Hypothermia, Accidental; Hypothermia
• Interventions: Behavioral: prevention training

• Registration Number: NCT04935632
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-15
• Study Start: 2021-06-21
• Study First Posted: 2021-06-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After implementation	prevention training	After implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia
at a distance from the implementation	prevention training	Approximately 8 months after implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hypothermia	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 Outcome Measures

Name	Time	Method
Intraoperative tympanic temperature	Up to 24 hours	From the time of entry into the operating room to the time of exit from the operating room.
Tympanic temperature in the post-anaesthesia care unit (PACU)	Up to 24 hours	From the time of entry into the PACU to the time of exit from the PACU.
Incidence of hypothermia in the post-anesthesia care unit (PACU)	Up to 24 hours	From the time of entry into the PACU, hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, Rhone, France