Forced-Air Warming for Preventing Perioperative Hypot

NCT07613203 | Terminated

• 1 other identifier: TKA-FAW-2018-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA. A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.

Conditions

Perioperative Hypothermia; Total Knee Arthroplasty

Keywords

Forced-Air Warming; Total Knee Arthroplasty; Perioperative Hypothermia; Temperature Management; Anesthesia Recovery

Outcome Measures

Primary Outcomes (1)

• Incidence of Inadvertent Perioperative Hypothermia

  The proportion of participants with core body temperature below 36.0°C at any perioperative time point.

  From anesthesia induction to 90 minutes after anesthesia completion

Study Arms (2)

Forced-Air Warming Group

EXPERIMENTAL

Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.

Device: Forced-Air Warming

Routine Warming Group

ACTIVE COMPARATOR

Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.

Other: Routine Passive Warming

Interventions

Forced-Air Warming DEVICE

Active perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit.

Forced-Air Warming Group

Routine Passive Warming OTHER

Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.

Routine Warming Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 60 and 85 years
• ASA physical status I or II
• Diagnosed with knee osteoarthritis
• Undergoing first unilateral primary total knee arthroplasty
• Able to provide written informed consent

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Study Officials

• Danling Fang, RN

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used because the forced-air warming intervention was visible to participants and care providers.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were assigned to two groups according to the study period. The historical control group received routine passive warming, and the intervention group received additional forced-air warming.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)