Perioperative Collection of Temperatures and Hypothermia (ROTHY)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Hypothermia; Anesthesia; Hypothermia, Accidental
• Intervention / Treatment: Behavioral: prevention training

• Study Type: Observational
• Enrollment (Actual): 388

Contacts and Locations

Study Locations

• France
  • Rhone
    • Lyon, Rhone, France, 69008
      • Centre Leon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients operated on at the Léon Bérard Centre, whether for scheduled, emergency or outpatient surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before implementation; Prior to the implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia
After implementation; After implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia	Behavioral: prevention training; Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room
at a distance from the implementation; Approximately 8 months after implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia.	Behavioral: prevention training; Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypothermia	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).	Up to 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Leon Berard

Publications and helpful links

General Publications

• Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: ROTHY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No