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

NCT03896867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-13

Study results available
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Summary

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

Conditions

  • Temperature Change, Body

Interventions

DEVICE

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit

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").

DEVICE

Bair Hugger™ Warming Blanket

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").

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2022-01-04
Completion
2022-01-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896867 on ClinicalTrials.gov