Poitiers University Hospital
Poitiers, 86000, France
Location status: Recruiting
NCT Number: NCT06551558
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Poitiers, 86000, France
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A systematic pre- and post-operative warming associated with the optimization of 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.
Time frame: 1 day
Proportion of patients with hypothermia after discharge of recovering room. Hypothermia is defined as a body temperature < 36°C.
Time frame: 1 day
it is the time between intubation and extubation, expressed in minutes.
Time frame: 1 day
evaluated by the Likert scale, ranging from 0 for discomfort too cold with strong chills to 4 for discomfort too hot with sweat with optimal comfort to 2 (self-assessment)
Time frame: 1 day
every 15minutes until discharge, evaluated by the Likert scale, ranging from 0 for discomfort too cold with strong chills to 4 for discomfort too hot with sweat with optimal comfort to 2 (self-assessment).
Time frame: 1 day
number of patient with body temperature under 36°C between arrival in pre-operative room and discharge of operating room
Time frame: 1 day
expressed in minutes.
Time frame: 1 day
expressed in minutes.
Time frame: 1 day
expressed in minutes.
Time frame: 1 day
the lowest temperture between arrival in the pre-anaesthesia room and exit from recovering room
Time frame: 1 day
number of patient with a temperature below 36°C
Time frame: 1 day
calculated from the introduction of oxygen therapy until its withdrawal in post extubation, regardless of the time of implementation or cessation before resumption of treatment (failure to withdraw oxygen therapy will not be considered), expressed in minutes.
Time frame: 1 day
number of patient with Nausea or Vomiting in recovering room evaluated every 15 minutes until discharge
Time frame: 1 day
number of chills during post-operative monitoring by a Likert scale
Time frame: 1 day
number of stirring phase evaluated every 15 minutes until discharge
Time frame: 1 day
blood loss measured from the time of entry into the operating theatre to the exit from the operating theatre expressed in millilitres.
Time frame: 1 day
blood loss measured in recovering room expressed in millilitres
Time frame: 1 day
the difference between the patient's lowest and highest temperature between their arrival in the pre-anaesthesia room and their exit from recovering room, expressed in degrees Celsius
Time frame: 1 day
the difference between the lowest and highest temperature of the patient between the arrival in the waiting room of the operating room and the arrival in the operating room, expressed in degrees Celsius
Time frame: 1 day
the difference between the lowest and highest temperature of the patient between the arrival and exit of the operating room, expressed in degrees Celsius
Time frame: 1 day
the difference between the lowest and highest temperature of the patient between arrival in and validation exit criteria of recovering room,expressed in degrees Celsius
Time frame: 1 day
difference between the time of arrival in recovering room and the time of obtaining the exit criteria , expressed in minutes.
Contact information is provided by the study sponsor or research team.
Poitiers University Hospital
Other
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
Acronym: REGLO
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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