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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04935632
Other study ID # ROTHY
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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