Warming Blanket Comparison Study

NCT04776954 | Terminated Results FDA Device

• 1 other identifier: ANES-2021-29543
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 5 hours

Secondary Outcomes (1)

• Body Temperature Upon Arrival in PACU

  up to 2 hours

Study Arms (2)

Forced Air Warming System

ACTIVE COMPARATOR

Participants in this arm will receive warming using a forced air warming system.

Device: Forced Air Warming System

Resistive Blanket Warming System

ACTIVE COMPARATOR

Participants in this arm will receive warming using a resistive blanket warming system.

Device: Resistive Blanket Warming System

Interventions

Forced Air Warming System DEVICE

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.

Forced Air Warming System

Resistive Blanket Warming System DEVICE

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.

Resistive Blanket Warming System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Undergoing elective renal transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Todd
• Organization: University of Minnesota

mmtodd@umn.edu

6126264551

Study Officials

• Cole Bennett, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: September 27, 2021
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)