Impact of a Global Warming Strategy of the Patient on the Prevalence of Hypothermia in the Recovering Room
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: global warming, per operative warming.
- Кому может быть актуально
- Состояния в реестре: Hypothermia; Anesthesia, Perioperative/Postoperative Complications. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое global warming
A systematic pre- and post-operative warming associated with the optimization of per-operative warming. - Другое 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.
Первичные конечные точки
- 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. [Срок оценки: 1 day]
Вторичные конечные точки (12)
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 1 day]
- 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) [Срок оценки: 1 day]
- 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) [Срок оценки: 1 day]
- 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 [Срок оценки: 1 day]
- 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 [Срок оценки: 1 day]
- Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average duration of oxygen therapy [Срок оценки: 1 day]
- 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 [Срок оценки: 1 day]
- 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 [Срок оценки: 1 day]
Критерии участия
Критерии включения
- Patient undergoing laparoscopic visceral surgery under general anesthesia with transition to recovering room
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Франция · 1 центр
- Poitiers University Hospital — Poitiers
Публикации
- 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 PMID 31869333
Идентификаторы
NCT: NCT06551558 · 2023-A02502-43