NCT02214524

Brief Summary

This is a randomized, open label, parallel two arm, clinical study, which compare the Bair Hugger forced-air warming blanket and the conventional warming care practice in China on patients undergoing major surgery to determine the impact of maintaining normothermia on intraoperative blood loss, requirement for transfusion of packed red blood cells and the changes of coagulation function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

August 8, 2014

Last Update Submit

August 15, 2014

Conditions

HypothermiaBlood Loss,Blood Coagulation Disorders

Keywords

perioperative hypothermiaTympanic temperatureBlood lossBlood Coagulation DisordersMajor surgery

Outcome Measures

Primary Outcomes (1)

  • Core Temperature and blood loss

    Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded

    intraoperative

Secondary Outcomes (5)

  • Length of Stay in PACU

    90 days after Hip replacement surgery and 30 days after other surgerys

  • Length of Stay in Hospital

    90 days after Hip replacement surgery and 30 days after other surgerys

  • Length of Stay in ICU

    90 days after Hip replacement surgery and 30 days after other surgerys

  • Surgical Site Infection（SSI）

    90 days after Hip replacement surgery and 30 days after other surgerys

  • coagulation function

    perioperative period

Study Arms (2)

Bair hugger forced air warming therapy

EXPERIMENTAL

Use of Bair Hugger forced-air warming system perioperatively to keep patient normothermia

Device: Bair Hugger forced air warming system

conventional warming care

NO INTERVENTION

conventional warming care

Interventions

Bair Hugger forced air warming systemDEVICE

Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery

Also known as: Bair Hugger 775, 70-2007-6800, Bair Hugger Blanket Model 635 and 300
Bair hugger forced air warming therapy

Eligibility Criteria

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

You may qualify if:

  • Adult patients≥18 years old
  • Preoperative core temperature between 36.0 and 37.5°C
  • American Society of Anaesthesiologists（ASA） Physical Status Classification System I-III
  • No transdermal meds on the target site
  • Elective major surgeries included but not limited:
  • Hip replacement
  • Thoracic surgery (lobectomy and esophagectomy) or abdominal surgery

You may not qualify if:

  • Less than 18 years old
  • Uncontrolled insulin-dependent diabetes mellitus (preoperative glucose \>250 mg/dL)
  • A preoperative temperature above 37.5°C or less than 36°C
  • Hyperthyroidism and hypothyroidism
  • Raynaud disease
  • History of infection and fever within 4 weeks before surgery
  • Use of steroid or immunosuppressant within 4 weeks before surgery
  • History of bleeding disorders
  • Clinically significant laboratory abnormalities
  • Hgb ≤ 10.0 g/L
  • Platelets ≤ 100,000 / mL
  • WBC（white blood cell ） \<3000/dL
  • Fibrinogen\<200 mg/dL
  • Thromboplastin time\>40s
  • Prothrombin time
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

  • Yi J, Liang H, Song R, Xia H, Huang Y. Maintaining intraoperative normothermia reduces blood loss in patients undergoing major operations: a pilot randomized controlled clinical trial. BMC Anesthesiol. 2018 Sep 8;18(1):126. doi: 10.1186/s12871-018-0582-9.

    PMID: 30193571DERIVED

MeSH Terms

Conditions

HypothermiaHemorrhageBlood Coagulation Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yugung Huang Huang, doctoral

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Liang

CONTACT

+86 13391994260805582814@qq.com

Ruiyue Song

CONTACT

+86 13261916376575514878@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 12, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

CN(1)