Surgery Clinical Trial
Official title:
Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
The purpose of the study is to compare the effectiveness of resistive blanket warming to forced air warming in maintaining body temperature in participants undergoing renal transplantation.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Undergoing elective renal transplantation Exclusion Criteria: - Previous surgery involving organ transplantation or nephrectomy. These patients are at higher risk of blood loss, making temperature regulation subject to more variables outside our control. - End stage renal disease with decreased or no urine output from normal. Bladder temperature will not be valid in these patients. - Previous upper extremity amputations - Ongoing sepsis or other infection - Thyroid dysfunction - Emergency surgery - Refusal of consent to participate in study - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC of Temperature vs Time | Outcome is reported as the Area Under Curve (AUC) of temperature vs time curve during hypothermia (core temperature less than 36 degrees Celcius) during the duration of surgery. Unit of measure is degrees Celsius per minute.
Time during surgery spent under 36 degrees Celsius through comparison of nasopharyngeal temperature, which is measured by placing a nasopharyngeal temperature probe 10 to 20 cm into the nare, between forced air warming system (FAWS) and resistive blanket warming system (RBWS). |
up to 5 hours | |
Secondary | Minimum body temperature upon arrival in PACU | Outcome is reported as the minimum body temperature recorded upon arrival in post-anesthesia care unit (PACU). | up to 2 hours | |
Secondary | Maximum body temperature difference upon arrival in PACU | Outcome us reported as the maximum difference in body temperature upon arrival in post-anesthesia care unit (PACU). | up to 2 hours | |
Secondary | First and Last PACU Temperature | Outcome is reported as body temperature in degrees Celsius. The first temperature and last taken while the patient is in the post-anesthesia care unit (PACU) will be reported. | at least 1 hour | |
Secondary | Participants requiring rescue intervention | Outcome is reported as the number of participants in each arm who require rescue intervention, which is defined as the need to turn on a second, upper body warming blanket if body temperature is consistently below 35.5 degrees. | up to 5 hours |
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