CHU de Liège
Liège, 4000, Belgium
NCT Number: NCT05213377
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Liège, 4000, Belgium
In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature.
Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery.
All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients.
The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients enrolled in surgery who will not receive 30 minutes of pulsed air thermal blanket warming prior to induction of anesthesia (3M™ Bair Hugger™ Adult Integral Blanket, Model 300 Dimensions: 213 cm x 91 cm)
Time frame: Intraoperative
Variation of core body temperature during surgery, i.e. the difference between the temperature at the time of induction of general anaesthesia and the minimum temperature recorded during the procedure, as well as its evolution over time.
Time frame: Intraoperative
Total intraoperative blood loss
Time frame: First 6 hours after surgery
The incidence of shivering in the first 6 hours post-surgery
Time frame: First 6 hours after surgery
Comfort in the recovery room by visual analogical scale (VAS 0-100)
Time frame: First 6 hours after surgery
Length of stay in the recovery room
Time frame: 30 days after surgery
Incidence of surgical site infection at 30 days postoperative
Time frame: 3 days after surgery
The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)
Time frame: Day-1 and Day-3 after surgery
Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)
Time frame: 30 days after surgery
Length of stay in hospital
University of Liege
Other
Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial
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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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