Perioperative Collection of Temperatures and Hypothermia

Hypothermia Clinical Trial

— ROTHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935632
• Other study ID #: ROTHY
• Status: Completed
• Start date: June 21, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Accidental
• Hypothermia; Anesthesia

Intervention

Behavioral:
• prevention training
Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon	Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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