Clinical trial NCT05213377: Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty
Official title: Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia Following Anesthesia
Hypothermia; Anesthesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 40
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: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2-3
* Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia

Exclusion Criteria:

* pregnant women
* patients with:

  1. peripheral neuropathy or other severe neurological pathology
  2. immunosuppression
  3. chronic renal insufficiency or severe hepatic insufficiency
  4. major congenital or acquired hemostasis disorders
  5. craniofacial dysmorphism or anatomical alterations of the upper airways
  6. known thermoregulatory disorders
* patients with a preoperative body temperature \> 37.5°C.

Primary outcomes:
measure: Core body temperature
timeFrame: Intraoperative
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Shivering
timeFrame: First 6 hours after surgery
measure: Patient comfort
timeFrame: First 6 hours after surgery
measure: Patient comfort
timeFrame: First 6 hours after surgery
measure: Surgical site infection
timeFrame: 30 days after surgery
measure: Postoperative complications
timeFrame: 3 days after surgery
measure: QoR-15
timeFrame: Day-1 and Day-3 after surgery
measure: LoS
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References:
citation: Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
citation: Simpson JB, Thomas VS, Ismaily SK, Muradov PI, Noble PC, Incavo SJ. Hypothermia in Total Joint Arthroplasty: A Wake-Up Call. J Arthroplasty. 2018 Apr;33(4):1012-1018. doi: 10.1016/j.arth.2017.10.057. Epub 2017 Nov 8.
citation: Akca O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5.
citation: McClain R, Bojaxhi E, Ford S, Hex K, Whalen J, Robards C. Forced-Air Convection Versus Underbody Conduction Warming Strategies to Maintain Perioperative Normothermia in Patients Undergoing Total Joint Arthroplasty. Cureus. 2020 Nov 13;12(11):e11474. doi: 10.7759/cureus.11474.