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

NCT ID: NCT06551558

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

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.

Detailed Description

Hypothermia is defined as a core temperature below 36°C. It is classified by severity stage. A temperature below 36°C is mild hypothermia, below 35°C moderate hypothermia and below 34°C severe hypothermia.

The impact of hypothermia on the body is related to decreased metabolic and immune activities. The vasoconstriction induced by hypothermia implies a decrease in vascularization of the organs that can cause tissue damage.

These effects explain the role of hypothermia in the pathophysiology of certain perioperative and postoperative complications in the longer term.

Intraoperative hypothermia is responsible for the increase of:

• 4 times the risk of Surgical Site Infection,
• twice the risk of cardiovascular morbidity, associated with increased mortality,
• 33% of transfusion need,
• 1.5 times the need for continued mechanical ventilation,
• 3 times the duration of recovering room,
• twice the hospital stay. This is why hypothermia is responsible for excess perioperative mortality.

According to a 2019 study (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), the prevalence of hypothermia increases from 16.2% of patients before anesthetic induction to 53.5% of patients admitted to the Recovering room. At the end of Recovering room, 33.2% of patients were hypothermic. Among these patients, 15.2% became hypothermic during the recovering room stay.

The risk factors for perioperative hypothermia are multiple:

Patient-related factors: low body mass index; undernutrition; ASA score > 1; pre-existing conditions altering thermoregulation (ex: diabetes with polyneuropathy, hypothyroidism, consumption of sedative or psychoactive drugs); pre-existing hypothermia at surgery.

Factors related to anesthesia techniques: duration of anesthesia > 2 hours; combined general and neuro-axial anesthesia; administration of large volumes of intravenous solutes or transfusion of non-rewarmed globular units.

Factors related to surgery: type, extent and duration of surgery witch use of large amounts of unheated irrigation fluid.

Conditions

Hypothermia; Anesthesia; Perioperative/Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RéGlo arm

Innovative support with global warming strategy.

Group Type: EXPERIMENTAL

global warming

Intervention Type: OTHER

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

Control arm

Support according to recommendations

Group Type: OTHER

per operative warming

Intervention Type: OTHER

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

Interventions

global warming

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

Intervention Type: OTHER

per operative warming

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Boisson, Pu-Ph

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Central Contacts

Marion Said

Role: CONTACT

marion.said@chu-poitiers.fr

0549444444

Nadia Teixeira

Role: CONTACT

nadia.teixeira@chu-poitiers.fr

References

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.

Reference Type: BACKGROUND

PMID: 31869333 (View on PubMed)

Other Identifiers

RéGlo

Identifier Type: -

Identifier Source: org_study_id