NCT03878901

Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome

Establishment of Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome-a Prospective Multiple Centers Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Participants enrolled into this trial will be from elective major surgery population in PUMC Hospital, Beijing Hospital and Xuanwu Hospital. investigators plan to enroll approximately 800 participants. Hypothermia risk will be evaluated through PREDICTOR model in all participants. According to hypothermia risk level, these participants will be stratefied into high, moderate and low risk group. Participants in each group will be randomly categorize into warm group and control group. Active warm and fluid warm strategy, prewarm and fluid warm strategy and only prewarm strategy are used for high risk, moderate risk and low risk patients seperately. For controll group traditional passive warm was used.

Conditions

• Hypothermia; Anesthesia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	high risk warm	Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming
COMBINATION_PRODUCT	moderate risk warm	30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation
COMBINATION_PRODUCT	low risk warm	30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation
OTHER	passive warming	cotton blanket warming through operation

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-03-31
• Completion: 2021-08-31
• First posted: 2019-03-18
• Last updated: 2019-03-18