Impact of a Global Warming Strategy of the Patient on the Prevalence of Hypothermia in the Recovering Room

NCT06551558 | Recruiting

• 1 other identifier: 2023-A02502-43
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

50% of patients are hypothermic when they arrive in the recovery room. This hypothermia is potentially at risk for the patient (increases bleeding, risk of infection, risk of cardiac involvement, morbid mortality) and 33,2% steel hypothermic when they discharge from the recovering room. The anesthesia team must prevent these risks through prevention and treatment measures. Currently the majority of patient warming is done only in the operating room, we want to measure the impact of the extension of this warming before and after the surgery on the patient's temperature and on side effects related to hypothermia.

Conditions

Hypothermia; Anesthesia; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery.

  Proportion of patients with hypothermia after discharge of recovering room. Hypothermia is defined as a body temperature \< 36°C.

  1 day

Secondary Outcomes (20)

• Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time

  1 day

• Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average thermal comfort of preoperative patients, on arrival in the pre- anesthesia room

  1 day

• Compare between the experimental group of global warming (RéGlo) and the control group of per- operative warming, the average thermal comfort of preoperative patients, on arrival in the recovering room

  1 day

• Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the proportion of patients in intraoperative hypothermia

  1 day

• Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 36°C (mild hypothermia)

  1 day

Study Arms (2)

RéGlo arm

EXPERIMENTAL

Innovative support with global warming strategy.

Other: global warming

Control arm

OTHER

Support according to recommendations

Other: per operative warming

Interventions

global warming OTHER

A systematic pre- and post-operative warming associated with the optimization of per-operative warming.

RéGlo arm

per operative warming OTHER

per-operative warming only thanks to the "Optimized" Forced air blanket with a prewarming of 10 minutes performed in the operating room.

Control arm

Eligibility Criteria

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

You may qualify if:

• Patient undergoing laparoscopic visceral surgery under general anesthesia with transition to recovering room

You may not qualify if:

• Patient undergoing urgent surgery.
• Presence of pre-existing infection (temperature higher than 38°C when receiving the patient in the hospital ward.
• Patient with predetermined length of stay in recovering room.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers University Hospital

Poitiers, 86000, France

RECRUITING

Related Publications (1)

• Alfonsi P, Bekka S, Aegerter P; SFAR Research Network investigators. Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France. PLoS One. 2019 Dec 23;14(12):e0226038. doi: 10.1371/journal.pone.0226038. eCollection 2019.

  PMID: 31869333 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Postoperative Complications

Interventions

Global Warming

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Climate Change; Climatic Processes; Ecological and Environmental Phenomena; Biological Phenomena

Study Officials

• Matthieu Boisson, Pu-Ph

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Said

CONTACT

0549444444; marion.said@chu-poitiers.fr

Nadia Teixeira

CONTACT

nadia.teixeira@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)