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Comparison of Active and Passive Perioperative Warming Techniques in Reducing Intraoperative Blood Loss

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ClinicalTrials.gov Identifier: NCT02214524
Recruitment Status : Unknown
Verified August 2014 by Jie YI, gwcmc.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Jie YI, gwcmc

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.

Condition or disease Intervention/treatment Phase
Hypothermia Blood Loss, Blood Coagulation Disorders Device: Bair Hugger forced air warming system Not Applicable

Detailed Description:

Each Investigator reviews the most current Instructions for Use for Bair Hugger Forced air Warming System to assess the contraindications, warnings, and precaution sections with respect to risks and benefits for treating potential patients.

60 patients will be enrolled preliminary in this clinical trial. Equal size of 30 patients were allocated randomly into interventional or control group.

Randomization will be performed after the patient has met all eligibility criteria, including the general inclusion or exclusion and the patient or legally authorized representative has signed an informed consent form prior to any study related procedure.

Prior to induction, patients in the interventional group were provided 15 to 30 minutes forced air warming using the Bair Hugger warming unit, either in the pre-anesthesia area or OR,which may add to the total heat content of the body helping to reduce the effects of redistribution temperature drop for procedures using a temperature management strategy. The Bair Hugger warming unit is placed on its highest temperature setting and will be adjusted by the investigator depending on temperature monitoring. Temperature will be measured in both groups by either Spot-On sensor and tympanic membrane thermometer.

Statistical analysis will be performed after the data of 30 cases (both groups) were available and the sample size will be re-estimated based on preliminary data analysis. Continuous variables will be summarized with mean, median, standard deviation, minimum and maximum, as applicable. Categorical variables will be summarized with frequency and percentage. Student t test will be used to compare means for continuous variables. A Chi square test or a Fisher's exact test will be used to compare proportions for categorical variables. Multiple regression will be performed to assess the risk ratios of patients developing hypothermia and will be expressed as an risk ratio along with a 95% confidence interval.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Active Warming System and Conventional Passive Warming Care in Reducing Intraoperative Blood Loss for Patients Undergoing Major Surgery
Study Start Date : August 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Bair hugger forced air warming therapy
Use of Bair Hugger forced-air warming system perioperatively to keep patient normothermia
Device: Bair Hugger forced air warming system
Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery
Other Names:
  • Bair Hugger 775, 70-2007-6800
  • Bair Hugger Blanket Model 635 and 300

No Intervention: conventional warming care
conventional warming care



Primary Outcome Measures :
  1. Core Temperature and blood loss [ Time Frame: intraoperative ]
    Monitor the changes of core temperature for whole perioperative period and the amount of blood loss were recorded


Secondary Outcome Measures :
  1. Length of Stay in PACU [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
  2. Length of Stay in Hospital [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
  3. Length of Stay in ICU [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
  4. Surgical Site Infection(SSI) [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
  5. coagulation function [ Time Frame: perioperative period ]
    take blood sample to detect the coagulation function,including Prothrombin time,Active Partial Thromboplastin Time,International normalized Ratio,Thromboelastography,Hemoglobin,ect.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • international normalized ratio(INR)<70%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214524


Contacts
Contact: Hao Liang +86 13391994260 805582814@qq.com
Contact: Ruiyue Song +86 13261916376 575514878@qq.com

Locations
China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100000
Contact: Jie YI, doctoral    +86 10 69152025    neyil@pumch.cn   
Principal Investigator: Yuguang Huang, doctoral         
Principal Investigator: Jie Yi, doctoral         
Sponsors and Collaborators
gwcmc
3M
Investigators
Principal Investigator: Yugung Huang Huang, doctoral gwcmc

Responsible Party: Jie YI, Vice director, gwcmc
ClinicalTrials.gov Identifier: NCT02214524     History of Changes
Other Study ID Numbers: MDI0092
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014

Keywords provided by Jie YI, gwcmc:
perioperative hypothermia
Tympanic temperature
Blood loss
Blood Coagulation Disorders
Major surgery

Additional relevant MeSH terms:
Hypothermia
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders