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Completed

NCT Number: NCT04935632

Perioperative Collection of Temperatures and Hypothermia

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Hypothermia, Accidental Hypothermia; Anesthesia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Léon Bérard

Lyon, Rhone, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prevention training

Behavioral

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

Primary outcomes

  1. Incidence of intraoperative hypothermia

    Time frame: 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).

Secondary outcomes

  1. Incidence of hypothermia in the post-anesthesia care unit (PACU)

    Time frame: Up to 24 hours

    From the time of entry into the PACU, hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).

  2. Tympanic temperature in the post-anaesthesia care unit (PACU)

    Time frame: Up to 24 hours

    From the time of entry into the PACU to the time of exit from the PACU.

  3. Intraoperative tympanic temperature

    Time frame: Up to 24 hours

    From the time of entry into the operating room to the time of exit from the operating room.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: ROTHY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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