Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients

Not Applicable

Completed

• Conditions: Temperature Change, Body
• Interventions: Device: Bair Hugger™ Warming Blanket; Device: Anapod™ Humi-Therm Heated Humidification System Breathing Circuit

• Registration Number: NCT03896867
• Lead Sponsor: University of Minnesota

Brief Summary

Our goal is to evaluate the efficacy of the Westmed system vs the Bair Hugger Blanket.

Detailed Description

Temperature management is an important aspect of perioperative care that falls under the purview of the anesthesiologist. Temperature is recognized as one of four primary vital signs and significant deviations from normal values may result in patient harm. General anesthesia disrupts the body's temperature homeostasis by inhibiting temperature regulation mechanisms such as vasoconstriction/-dilation, shivering and behavioral interventions (donning clothes or leaving an area with excessive heat, for example). Anesthetized patient have a tendency to become hypothermic, especially during long surgical procedures. This results from both the redistribution of cooler peripheral temperatures into the core (due to vasodilation) as well as actual temperature loss to a cold operating room environment (which is maintained at a lower temperature for the comfort of fully gowned surgeons and nurses). In addition, large surgical incisions predispose the patient to hypothermia through evaporation and convection.

Hypothermia is a recognized risk factor that predisposes the patient to an increased metabolic rate, increased oxygen demand, coagulopathies, impaired wound healing, impaired immune function and increased risk of infection. Therefore, maintenance of normal body temperature is an important goal of every general anesthetic - and is a well-accepted quality metric associated with patient care. Because of the greater surface area to volume relationship, children are thought to be a greater risk of intraoperative hypothermia.

The most widely used method of maintaining body temperature during surgery (and a routine at this institution) is by using a forced-air warming blanket (Bair Hugger warming blanket, 3M). Despite its widespread use, the forced-air warming blanket has its limitations. For example, during certain surgical procedures, the location of the surgical field precludes placement of the warming blanket. In addition, the warming blanket often cannot be placed immediately after the induction of anesthesia (when complex patient positioning is required) - leaving the patient exposed to hypothermic conditions for short (10-15min) or long (30-60min) periods of time. There is hence a need for alternative warming systems that could be implemented immediately following anesthetic induction.

Westmed, Inc. has developed an alternative system that utilizes a heated, humidified breathing circuit to regulate a patient's body temperature in the intraoperative setting. This system is active from the moment the trachea is intubated following anesthetic induction, i.e. there are no delays in instituting thermal management.

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: 2019-03-21
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Study Start: 2019-10-31
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation, anticipated to last 1-6 hours or longer

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Exclusion Criteria

• Parent refusal of consent
• Patient refusal of assent (if applicable)
• Additional procedures (combined procedures) that involve other specialties besides dentists and other parts of the patient's body other than the oral cavity.
• History of diseases associated with temperature dysregulation (active hyperthyroidism, dysautonomia, osteogenesis imperfecta, history of malignant hyperthermia)
• Patients that will not be intubated for the procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bair Hugger™ Warming Blanket	Bair Hugger™ Warming Blanket	Patient warming will be provided via the Bair Hugger™ Warming Blanket.
Anapod™ Humi-Therm Heated Humidification System	Anapod™ Humi-Therm Heated Humidification System Breathing Circuit	Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.

Primary Outcome Measures

Name	Time	Method
Rectal Temperature	study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours	Last measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.

Secondary Outcome Measures

Name	Time	Method
Need for Hyperthermic or Hypothermic Rescue	study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours	Procedures for hyperthermic and hypothermic rescue can be found in the arm description section. Total number of rescue events will be compared between groups. A greater number of events indicates worse performance for that temperature control method.
Cumulative degree-minutes above and below 37C	study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours	Two temperature recording devices will be used: 3M SpotOn™ Forehead Temperature probe, (used routinely in the operating rooms and postoperative recovery areas) and a standard rectal thermistor probe. Cumulative minutes that patients spend above or below 37C will be compared between groups. A larger sum of degree-minutes above and below 37C indicates worse performance for that temperature control method.

Trial Locations

Locations (1)

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