Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Impact of a Global Warming Strategy of the Patient on the Prevalence of Hypothermia in the Recovering Room
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 332 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 patients temperature and on side effects related to hypothermia
Detailed Description:
Hypothermia is defined as a core temperature below 36C It is classified by severity stage A temperature below 36C is mild hypothermia below 35C moderate hypothermia and below 34C 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
15 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 162 of patients before anesthetic induction to 535 of patients admitted to the Recovering room At the end of Recovering room 332 of patients were hypothermic Among these patients 152 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
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
15 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 162 of patients before anesthetic induction to 535 of patients admitted to the Recovering room At the end of Recovering room 332 of patients were hypothermic Among these patients 152 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None