CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Anapod™ Humi-Therm Heated Humidification System Breathing Circuit +1 moredevice
Likely dose
Anapod™ Humi-Therm: starting circuit temperature 45°C; Bair Hugger™: starting temperature set at HIGHAI-extracted
Key inclusion· 2
  • Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation
  • Anticipated procedure duration 1-6 hours or longer
Key exclusion· 4
  • Parent refusal of consent or patient refusal of assent (if applicable)
  • Combined procedures involving other specialties or body parts beyond the oral cavity
  • History of diseases associated with temperature dysregulation: active hyperthyroidism, dysautonomia, osteogenesis imperfecta, or history of malignant hyperthermia
  • Patients who will not be intubated for the procedure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03896867
NCT03896867N/ACompleted

Anapod™ Humi-Therm Heated Humidification System Breathing Circuit Versus Bair Hugger™ Warming Blanket for Intraoperative Maintenance of Body Temperature in Pediatric Patients Undergoing Dental Procedures: a Prospective Randomized Non-Inferiority Study

University of Minnesota·interventional·Posted Apr 1, 2019·Updated Mar 13, 2025

In Brief

A clinical study evaluating Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and Bair Hugger™ Warming Blanket for Temperature Change, Body. Completed, enrolled 100 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartOct 31, 2019
Primary CompletionJan 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.3 years ago

Interventions

Anapod™ Humi-Therm Heated Humidification System Breathing Circuitdevice

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").

Bair Hugger™ Warming Blanketdevice

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").