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, Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : August 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia Blood Loss, Blood Coagulation Disorders||Device: Bair Hugger forced air warming system||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
No Intervention: conventional warming care
conventional warming care
- 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
- Length of Stay in PACU [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
- Length of Stay in Hospital [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
- Length of Stay in ICU [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
- Surgical Site Infection（SSI） [ Time Frame: 90 days after Hip replacement surgery and 30 days after other surgerys ]
- 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.
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
|Contact: Hao Liang||+86 firstname.lastname@example.org|
|Contact: Ruiyue Song||+86 email@example.com|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100000|
|Contact: Jie YI, doctoral +86 10 69152025 firstname.lastname@example.org|
|Principal Investigator: Yuguang Huang, doctoral|
|Principal Investigator: Jie Yi, doctoral|
|Principal Investigator:||Yugung Huang Huang, doctoral||Peking Union Medical College Hospital|