Study Results
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View full resultsBasic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2021-09-27
2022-11-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Forced Air Warming System
Participants in this arm will receive warming using a forced air warming system.
Forced Air 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.
Resistive Blanket Warming System
Participants in this arm will receive warming using a resistive blanket warming system.
Resistive Blanket Warming System
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.
Interventions
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Forced Air 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.
Resistive Blanket Warming System
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Cole Bennett, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ANES-2021-29543
Identifier Type: -
Identifier Source: org_study_id
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