Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Anesthesia; Hypothermia Following Anesthesia
• Intervention / Treatment: Procedure: Preoperative warming

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group C; 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 not receive the 30 minutes of preoperative warming through pulsed air thermal coverage.
Experimental: Group W; 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.	Procedure: Preoperative warming; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core body temperature	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.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Total intraoperative blood loss	Intraoperative
Shivering	The incidence of shivering in the first 6 hours post-surgery	First 6 hours after surgery
Patient comfort	Comfort in the recovery room by visual analogical scale (VAS 0-100)	First 6 hours after surgery
Patient comfort	Length of stay in the recovery room	First 6 hours after surgery
Surgical site infection	Incidence of surgical site infection at 30 days postoperative	30 days after surgery
Postoperative complications	The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)	3 days after surgery
QoR-15	Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)	Day-1 and Day-3 after surgery
LoS	Length of stay in hospital	30 days after surgery

Collaborators and Investigators

• Sponsor: University of Liege

Publications and helpful links

General Publications

• 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.
• 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.
• Akca O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Thermo-ATHA22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No