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

NCT03896867 | Completed Results FDA Device

• 1 other identifier: ANES-2019-27433
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temperature Change, Body

Keywords

Temperature management; Perioperative temperature management; Pediatric temperature management; Pediatric perioperative temperature management

Outcome Measures

Primary Outcomes (1)

• Rectal Temperature

  Last measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.

  study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours

Secondary Outcomes (1)

• Need for Hyperthermic or Hypothermic Rescue

  study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours

Study Arms (2)

Anapod™ Humi-Therm Heated Humidification System

EXPERIMENTAL

Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.

Device: Anapod™ Humi-Therm Heated Humidification System Breathing Circuit

Bair Hugger™ Warming Blanket

ACTIVE COMPARATOR

Patient warming will be provided via the Bair Hugger™ Warming Blanket.

Device: Bair Hugger™ Warming Blanket

Interventions

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit DEVICE

For the Anapod™ group, the BairHugger™ blanket will be connected, but the unit will not be turned on. The Anapod™ will be used with a starting circuit temperature set at the standard 45°C (note, this is temperature at the unit - NOT the temperature of the gas reaching the trachea). In the event that the patient's rectal temperature falls below 35.6C, the BairHugger™ warming system will be activated ("Hypothermic Rescue"). In the event that rectal temperature increases to a value of ≥37.5C, the Anapod system will be turned off - and the BairHugger turned on with the warming unit set to "ambient" (meaning cool operating room temperature will be blown over the patient ("Hyperthermic Rescue").

Anapod™ Humi-Therm Heated Humidification System

Bair Hugger™ Warming Blanket DEVICE

For the BairHugger™ group, the blanket will be used with a starting temperature set at HIGH. The BairHugger™ unit will be attached to the warming unit and started as soon as possible. In the event that the patient's rectal temperature falls below 35.6C, the Anapod™ warming system will be activated ("Rescue"). In the event that rectal temperature increases to a value of ≥37.5C, the BairHugger™ warming unit will be set to "ambient" (meaning cool operating room temperature will be blown over the patient ("Hyperthermic Rescue").

Bair Hugger™ Warming Blanket

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

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: Benjamin Kloesel
• Organization: University of Minnesota

bkleosel@umn.edu

612-301-1245

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment will be blinded with the data set (Group A vs B) for review purposes - although it is important to note that true blinding of the providers (including on PI and Co PI) is impossible for this procedural study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 1, 2019
• Study Start: October 31, 2019
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)