Clinical trial NCT06551558: Impact of a Global Warming Strategy of the Patient on the Prevalence of Hypothermia in the Recovering Room
Official title: Impact of a Global Warming Strategy, From the Patient Arrival in the Operating Room to His Discharge From the Recovering Room, Versus a Recommended Management of Intraoperative Warming on the Prevalence of Hypothermia in the Recovering Room
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypothermia; Anesthesia
Perioperative/Postoperative Complications
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 1 day
Secondary outcomes:
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the proportion of patients in intraoperative hypothermia
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 35°C (moderate hypothermia)
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 34°C (severe hypothermia)
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The lowest average temperature reached in °C over the entire management
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The proportion of hypothermic patients arriving in recovering room
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average duration of oxygen therapy
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of Nausea or Vomiting Postoperative
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of chills
timeFrame: 1 day
measure: Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of stirring phase presence
timeFrame: 1 day
measure: The average amount of blood loss per operation
timeFrame: 1 day
measure: The average of immediate post-operative blood loss
timeFrame: 1 day
measure: The general average of the thermal variation
timeFrame: 1 day
measure: The average of thermal variation in pre operative
timeFrame: 1 day
measure: The average thermal variation in per operative
timeFrame: 1 day
measure: the average thermal variation in post operative
timeFrame: 1 day
measure: The average length of stay in recovering room
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Poitiers University Hospital
name: Matthieu Boisson, Pu-Ph
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.