NCT05213377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

January 3, 2022

Last Update Submit

November 9, 2022

Conditions

Hypothermia Following AnesthesiaHypothermia; Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Intraoperative blood loss

    Intraoperative

  • Shivering

    First 6 hours after surgery

  • Patient comfort

    First 6 hours after surgery

  • Patient comfort

    First 6 hours after surgery

  • Surgical site infection

    30 days after surgery

  • +3 more secondary outcomes

Study Arms (2)

Group C

NO INTERVENTION

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.

Group W

EXPERIMENTAL

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

Interventions

Preoperative warmingPROCEDURE

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)

Group W

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2-3
  • Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 26775126BACKGROUND

  • 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.

    PMID: 29195854BACKGROUND

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

    PMID: 12024079BACKGROUND

  • 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.

    PMID: 33329970BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Unblinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic, Anesthesiology and Intensive Care Department

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 28, 2022

Study Start

January 5, 2022

Primary Completion

October 19, 2022

Study Completion

October 20, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)