Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
Primary Purpose
Surgery, Temperature Change, Body
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forced Air Warming System
Resistive Blanket Warming System
Sponsored by
About this trial
This is an interventional basic science trial for Surgery
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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Forced Air Warming System
Resistive Blanket Warming System
Arm Description
Participants in this arm will receive warming using a forced air warming system.
Participants in this arm will receive warming using a resistive blanket warming system.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Minimum body temperature upon arrival in PACU
Outcome is reported as the minimum body temperature recorded upon arrival in post-anesthesia care unit (PACU).
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).
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.
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.
Full Information
NCT ID
NCT04776954
First Posted
February 25, 2021
Last Updated
May 11, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04776954
Brief Title
Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
Official Title
Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Temperature Change, Body
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Forced Air Warming System
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive warming using a forced air warming system.
Arm Title
Resistive Blanket Warming System
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive warming using a resistive blanket warming system.
Intervention Type
Device
Intervention Name(s)
Forced Air Warming System
Intervention Description
The forced air warming system has a heater unit that blows air through a conduit to an "air blanket" that inflates with forced air that circulates throughout the blanket, and exits through tiny perforations on the patient-side of that blanket. The heat primarily warms the subject through convective means. As the warmed air escapes through the perforations in the blanket, it creates an environment of continuously circulating warm air that is in contact with the skin.
Intervention Type
Device
Intervention Name(s)
Resistive Blanket Warming System
Intervention Description
This blanket is equivalent to an operating-room-safe electric blanket. Through a power cord, a separate power source powers a semiconductor layer within the resistive blanket to generate heat. The heat primarily warms the subject by conductive warming through direct skin contact, and, secondarily, by warming the air around the participant in areas where there is no direct skin contact.
Primary Outcome Measure Information:
Title
AUC of Temperature vs Time
Description
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).
Time Frame
up to 5 hours
Secondary Outcome Measure Information:
Title
Minimum body temperature upon arrival in PACU
Description
Outcome is reported as the minimum body temperature recorded upon arrival in post-anesthesia care unit (PACU).
Time Frame
up to 2 hours
Title
Maximum body temperature difference upon arrival in PACU
Description
Outcome us reported as the maximum difference in body temperature upon arrival in post-anesthesia care unit (PACU).
Time Frame
up to 2 hours
Title
First and Last PACU Temperature
Description
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.
Time Frame
at least 1 hour
Title
Participants requiring rescue intervention
Description
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.
Time Frame
up to 5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cole Bennett, MD
Phone
716-725-7975
Email
bennettc@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cole Bennett, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery
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