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

NCT03878901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yuguang Huang, doctor · Peking Union Medcial College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-03-31
Completion
2021-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878901 on ClinicalTrials.gov