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Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

Primary Purpose

Hypothermia Following Anesthesia, Hypothermia; Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Preoperative warming
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia Following Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group C

Group W

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2022
Last Updated
November 9, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05213377
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Following Anesthesia, Hypothermia; Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Unblinded
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
No Intervention
Arm Description
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.
Arm Title
Group W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Preoperative warming
Intervention Description
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)
Primary Outcome Measure Information:
Title
Core body temperature
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Total intraoperative blood loss
Time Frame
Intraoperative
Title
Shivering
Description
The incidence of shivering in the first 6 hours post-surgery
Time Frame
First 6 hours after surgery
Title
Patient comfort
Description
Comfort in the recovery room by visual analogical scale (VAS 0-100)
Time Frame
First 6 hours after surgery
Title
Patient comfort
Description
Length of stay in the recovery room
Time Frame
First 6 hours after surgery
Title
Surgical site infection
Description
Incidence of surgical site infection at 30 days postoperative
Time Frame
30 days after surgery
Title
Postoperative complications
Description
The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)
Time Frame
3 days after surgery
Title
QoR-15
Description
Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)
Time Frame
Day-1 and Day-3 after surgery
Title
LoS
Description
Length of stay in hospital
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: peripheral neuropathy or other severe neurological pathology immunosuppression chronic renal insufficiency or severe hepatic insufficiency major congenital or acquired hemostasis disorders craniofacial dysmorphism or anatomical alterations of the upper airways known thermoregulatory disorders patients with a preoperative body temperature > 37.5°C.
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26775126
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.
Results Reference
background
PubMed Identifier
29195854
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.
Results Reference
background
PubMed Identifier
12024079
Citation
Akca O, Sessler DI. Thermal management and blood loss during hip arthroplasty. Minerva Anestesiol. 2002 Apr;68(4):182-5.
Results Reference
background
PubMed Identifier
33329970
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.
Results Reference
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Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

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