Hypothermia Clinical Trial
Official title:
Comparison of Active Warming System and Conventional Passive Warming Care in Reducing Intraoperative Blood Loss for Patients Undergoing Major Surgery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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