Perioperative Collection of Temperatures and Hypothermia

NCT04935632 | Completed

• 1 other identifier: ROTHY
• Study Type: observational
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Hypothermia; Anesthesia; Hypothermia, Accidental

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Intraoperative tympanic temperature

  Up to 24 hours

Study Arms (3)

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

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

Interventions

prevention training BEHAVIORAL

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

After implementation; at a distance from the implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, Rhone, 69008, France

Location

Related 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.

  PMID: 33616248 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 23, 2021
• Study Start: June 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)