An interventional study of Forced Air Warming System and Resistive Blanket Warming System in Surgery and Temperature Change, Body, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science
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.
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
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Participants in this arm will receive warming using a forced air warming system.
Device: Forced Air Warming System
Participants in this arm will receive warming using a resistive blanket warming system.
Device: Resistive Blanket Warming System
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.
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.
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).
Time frame: up to 5 hours
Body Temperature Upon Arrival in PACU
Outcome is reported as the body temperature recorded upon arrival in post-anesthesia care unit (PACU).
Time frame: up to 2 hours
| Milestone | Forced Air Warming System | Resistive Blanket Warming System |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
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).
| celsius per minute | Forced Air Warming System | Resistive Blanket Warming System |
|---|---|---|
| AUC of Temperature vs Time | -131 ± 93 | -147 ± 69 |
Outcome is reported as the body temperature recorded upon arrival in post-anesthesia care unit (PACU).
| celsius per minute | Forced Air Warming System | Resistive Blanket Warming System |
|---|---|---|
| Body Temperature Upon Arrival in PACU | 36.8 ± 0.5 | 37 ± 0.3 |
Collected over No adverse event were reported. The study participants were only on the study for the time of warming blanket and was very minimal risk.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Forced Air Warming System | — | — | — |
| Resistive Blanket Warming System | — | — | — |
| Age, Categorical(Participants) | Forced Air Warming System | Resistive Blanket Warming System | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 6 | 11 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Forced Air Warming System | Resistive Blanket Warming System | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 6 | 4 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Forced Air Warming System | Resistive Blanket Warming System | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 6 | 12 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Forced Air Warming System | Resistive Blanket Warming System | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 6 | 7 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2021 to primary completion in Nov 2022, 13 months.
Results were first posted in Sep 2024, 1 year 10 months after primary completion.
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