Clinical trial NCT04776954: Warming Blanket Comparison Study
Official title: Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Temperature Change, Body
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The study will involve two arms: a resistive blanket warming system arm and a forced air warming system arm. Both devices will be set to warm the participant at a standard 41 degrees Celsius when the participant is to be rewarmed.

During the study, the forced air warming system (FAWS) will be placed on the (resistive blanket warming system (RBWS), with the participant laying on top of the forced air warming system. The arm components will be wrapped around the participant's arms to assist with patient positioning for surgery. Both the forced air and resistive blanket warming systems will be attached to their respective heating units before the participant is brought to the OR and transferred to the operating room table. After the needed standard monitors for surgery have been placed, general anesthesia will be induced and maintained with participant's hemodynamics and other vitals maintained per standard care (no additional measurements beyond standard of care which is recorded in EPIC). The certified registered nurse anesthetists (CRNA) will be involved in the placement of the blankets. Operating Room Nurse managers and CRNA's will be informed by research team regarding participant's involvement in the study.

Participant's core temperature will be measured with a nasopharyngeal temperature probe. Vital signs, including continuous blood pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide, will be monitored and recorded in Epic as is routine with all anesthetics performed.

Standard anesthetic care of the participant will occur for the duration of the surgery. The participant will be randomized to either the FAWS or RBWS before arrival to the operating room. The participant's temperature will be monitored and recorded for the duration of surgery with the selected warming system. The primary outcome variable is the nasopharyngeal temperature as recorded at the end of the surgery.

Temperature measurement in the PACU will be standardized with skin temperature probes that will be placed on the forehead prior to leaving the operating room.

Eligibility criteria: 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

Primary outcomes:
measure: AUC of Temperature vs Time
timeFrame: up to 5 hours
Secondary outcomes:
measure: Body Temperature Upon Arrival in PACU
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cole Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References: