Skip to content

Clinical and Health Economic Benefits of Active Warming System

A Randomized, Controlled, Open-Label Clinical Trial Comparing Both Clinical and Health Economic Benefits of Active Warming Using Bair HuggerTM Forced Air Warming System Compared to the Standard of Care in Subjects Undergoing Major Surgeries

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011099
Enrollment
Unknown
Registered
2017-04-09
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-10-23

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

Conditions

Major Surgeries

Interventions

Active warming group: FAW starts at least 30 min preoperatively and then continue throughout the entire operation. Air forced blankets (Bair Hugger, 3M, Minnesota, USA), connected to its corresponding
Passive warming group:CBW is currently the standard of care in China according to our previous survey results in China. CBW care starts at least 30 min preoperatively and then continue throughout the

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients=18 years old; 2. Preoperative core temperature between 36.0 and 37.5 degree C; 3. ASA Physical Status Classification System I-III; 4. One of the following elective major surgeries; 5. Colectomy; 6. Esophagectomy.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose >250 mg/dL) 2. A preoperative temperature above 37.5°C 3. Hyperthyroidism and hypothyroidism 4. Raynaud disease 5. History of infection and fever within 4 weeks before surgery 6. Use of steroid or immunosuppressant within 4 weeks before surgery 7. History of bleeding disorders 8. Clinically significant laboratory abnormalities Hgb = 10.0 g/L; Platelets = 100,000/mL; WBC 14,000/dL; Fibrinogen40s; Prothrombin time (INR<70%) (Normal range 70%-140%).

Design outcomes

Primary

MeasureTime frame
incidence of intraoperative hypothermia;intraoperative blood loss/blood transfusion;surgical site infection (SSI);Cost;

Countries

China

Contacts

Public ContactGuangyu Huang, Aixia Ma

Peking Union Medical College Hospital/China Pharmaceutical University

hellohigh@163.com+86 13611383025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026