Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

Hypothermia; Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213377
• Other study ID #: Thermo-ATHA22
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: November 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Following Anesthesia
• Hypothermia; Anesthesia

Intervention

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)

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Akça O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

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