Skip to content

Forced-Air Warming for Preventing Perioperative Hypot

Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07613203
Enrollment
240
Registered
2026-05-29
Start date
2018-05-01
Completion date
2019-01-31
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Hypothermia, Total Knee Arthroplasty

Keywords

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

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.

Detailed description

This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA). A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period. The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter. The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection. This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.

Interventions

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.

OTHERRoutine Passive Warming

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

Sponsors

Shanghai 6th People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

No masking was used because the forced-air warming intervention was visible to participants and care providers.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Inadvertent Perioperative HypothermiaFrom anesthesia induction to 90 minutes after anesthesia completionThe proportion of participants with core body temperature below 36.0°C at any perioperative time point.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORDanling Fang, RN

Shanghai 6th People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026