Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery

Not Applicable

Recruiting

• Conditions: Temperature Change, Body; Surgery
• Interventions: Device: Forced Air Warming System; Device: Resistive Blanket Warming System

• Registration Number: NCT04776954
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Study Start: 2021-09-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Undergoing elective renal transplantation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forced Air Warming System	Forced Air Warming System	Participants in this arm will receive warming using a forced air warming system.
Resistive Blanket Warming System	Resistive Blanket Warming System	Participants in this arm will receive warming using a resistive blanket warming system.

Primary Outcome Measures

Name	Time	Method
AUC of Temperature vs Time	up to 5 hours	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).

Secondary Outcome Measures

Name	Time	Method
Body Temperature Upon Arrival in PACU	up to 2 hours	Outcome is reported as the body temperature recorded upon arrival in post-anesthesia care unit (PACU).

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States