ROTHY: Perioperative Collection of Temperatures and Hypothermia

Sponsor
Centre Leon Berard (Other)
Overall Status
Recruiting
CT.gov ID
NCT04935632
Collaborator
(none)
300
1
13.3
22.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: prevention training

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)
Actual Study Start Date :
Jun 21, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Incidence of hypothermia on arrival in the post-anesthesia care unit (PACU) [Up to 24 hours]

    On arrival in the PACU, hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

Secondary Outcome Measures

  1. 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).

  2. Incidence of hypothermia 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. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

  3. Delta Temperature Loss [Up to 24 hours]

    difference in patient temperature between arrival in the operating room and the lowest temperature measured in the operating room or in PACU

  4. Incidence of continued sedation in the PACU partially or totally related to hypothermia [Up to 24 hours]

    defined as continued sedation requiring mechanical ventilation in the PACU

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Léon Bérard Lyon Rhone France 69008

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT04935632
Other Study ID Numbers:
  • ROTHY
First Posted:
Jun 23, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022