NCT03878901

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 13, 2019

Last Update Submit

March 14, 2019

Conditions

Hypothermia; Anesthesia

Keywords

hypothermia

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative hypothermia

    Core temperature\<36℃

    During operation

Secondary Outcomes (13)

  • The amount of Intraoperative blood loss/blood transfusion

    During operation

  • Length of stay in PACU

    Postoperative during in postanaesthesia care unit， up to 24 hours after surgery

  • The incidence of Surgical site infection

    WIthin 30 days postoperative

  • Lenght of Stay in hospital

    impatient period， up to 6 month after surgery

  • Lenght of Stay in ICU

    impatient period， up to 6 month after surgery

  • +8 more secondary outcomes

Study Arms (2)

control group

SHAM COMPARATOR

Cotton Blanket Warming (CBW) starts 30 min preoperatively and then continues throughout the entire operation.

Other: passive warming

warm group

EXPERIMENTAL

Warm according to different hypothermia risk for low risk ---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) continues throughout the entire operation. moderate risk---Forced-air warming(FAW) starts at least 30 min preoperatively and then Cotton Blanket Warming (CBW) and fluid warming continues throughout the entire operation. high risk ----Forced-air warming(FAW) starts at least 30 min preoperatively, FAW and fluid warming continues throughout the entire operation.

Combination Product: high risk warmCombination Product: moderate risk warmCombination Product: low risk warm

Interventions

high risk warmCOMBINATION_PRODUCT

Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming

warm group
moderate risk warmCOMBINATION_PRODUCT

30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation

warm group
low risk warmCOMBINATION_PRODUCT

30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation

warm group
passive warmingOTHER

cotton blanket warming through operation

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent

You may not qualify if:

  • emergency operation
  • uncontrolled diebete mellitus with insulin treatment （preoperative blood glucose\>250mg/dL）
  • hyperthyroidism and hypothyroidism
  • Raynaud's disease
  • patients with hematopathy and immune disease
  • anticoagulant and non-steroid anti-inflammatory drug intake with 14 days before operation
  • infectious fever within 4 weeks before operation
  • laboratory abnomality as follow
  • Hemoglobin≤10.0g/L
  • Platelet≤100,000/ml
  • White blood cell\<3000/dl or\>14,000/dl
  • Fibrinogen\<200mg/dL
  • Thrombin time\>40 second
  • International normalized ratio\<70%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Yi J, Xiang Z, Deng X, Fan T, Fu R, Geng W, Guo R, He N, Li C, Li L, Li M, Li T, Tian M, Wang G, Wang L, Wang T, Wu A, Wu D, Xue X, Xu M, Yang X, Yang Z, Yuan J, Zhao Q, Zhou G, Zuo M, Pan S, Zhan L, Yao M, Huang Y. Incidence of Inadvertent Intraoperative Hypothermia and Its Risk Factors in Patients Undergoing General Anesthesia in Beijing: A Prospective Regional Survey. PLoS One. 2015 Sep 11;10(9):e0136136. doi: 10.1371/journal.pone.0136136. eCollection 2015.

    PMID: 26360773BACKGROUND

  • Yi J, Zhan L, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Yao M, Huang Y. Establishment and Validation of a Prediction Equation to Estimate Risk of Intraoperative Hypothermia in Patients Receiving General Anesthesia. Sci Rep. 2017 Oct 24;7(1):13927. doi: 10.1038/s41598-017-12997-x.

    PMID: 29066717RESULT

  • Yi J, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Xiang Z, Pan S, Zhan L, Qiu K, Yao M, Huang Y. Intraoperative hypothermia and its clinical outcomes in patients undergoing general anesthesia: National study in China. PLoS One. 2017 Jun 8;12(6):e0177221. doi: 10.1371/journal.pone.0177221. eCollection 2017.

    PMID: 28594825RESULT

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuguang Huang, doctor

    Peking Union Medcial College Hospital

    STUDY CHAIR

Central Study Contacts

Jiaxin Lang, doctor

CONTACT

13611119094langjx09@163.com

Jie Yi, doctor

CONTACT

13701362812neyil@pumch.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 18, 2019

Study Start

April 1, 2019

Primary Completion

March 31, 2021

Study Completion

August 31, 2021

Last Updated

March 18, 2019

Record last verified: 2019-03