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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05213377
Other study ID # Thermo-ATHA22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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