Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hypothermia Following Anesthesia; Hypothermia; Anesthesia
• Interventions: Procedure: Preoperative warming

• Registration Number: NCT05213377
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2022-01-03
• Study Start: 2022-01-05
• Study First Submitted QC: 2022-01-15
• Study First Posted: 2022-01-28
• Primary Completion: 2022-10-19
• Study Completion: 2022-10-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group W	Preoperative warming	Patients undergoing total hip replacement surgery by anterior approach, with general anesthesia and continuous core body temperature measurement via nasopharyngeal thermic probe. Patients recruited for surgery who will receive the 30 minutes of preoperative warming through pulsed air thermal coverage.

Primary Outcome Measures

Name	Time	Method
Core body temperature	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.

Secondary Outcome Measures

Name	Time	Method
Surgical site infection	30 days after surgery	Incidence of surgical site infection at 30 days postoperative
Shivering	First 6 hours after surgery	The incidence of shivering in the first 6 hours post-surgery
QoR-15	Day-1 and Day-3 after surgery	Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)
Intraoperative blood loss	Intraoperative	Total intraoperative blood loss
LoS	30 days after surgery	Length of stay in hospital
Patient comfort	First 6 hours after surgery	Length of stay in the recovery room
Postoperative complications	3 days after surgery	The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium