Trial Outcomes & Findings for Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients (NCT NCT03896867)
NCT ID: NCT03896867
Last Updated: 2025-03-13
Results Overview
Last measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
Anapod™ Humi-Therm Heated Humidification System
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").
|
Bair Hugger™ Warming Blanket
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Anapod™ Humi-Therm Heated Humidification System
n=50 Participants
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").
|
Bair Hugger™ Warming Blanket
n=50 Participants
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hoursLast measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.
Outcome measures
| Measure |
Anapod™ Humi-Therm Heated Humidification System
n=50 Participants
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").
|
Bair Hugger™ Warming Blanket
n=50 Participants
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").
|
|---|---|---|
|
Rectal Temperature
|
36.7 degrees celsius
Standard Deviation 0.47
|
37.2 degrees celsius
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hoursProcedures 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.
Outcome measures
| Measure |
Anapod™ Humi-Therm Heated Humidification System
n=50 Participants
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").
|
Bair Hugger™ Warming Blanket
n=50 Participants
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").
|
|---|---|---|
|
Need for Hyperthermic or Hypothermic Rescue
|
11 rescue events
|
22 rescue events
|
Adverse Events
Anapod™ Humi-Therm Heated Humidification System
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Bair Hugger™ Warming Blanket
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anapod™ Humi-Therm Heated Humidification System
n=50 participants at risk
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").
|
Bair Hugger™ Warming Blanket
n=50 participants at risk
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").
|
|---|---|---|
|
General disorders
prolonged hospitalization
|
2.0%
1/50 • Number of events 1 • 6 hours
|
4.0%
2/50 • Number of events 2 • 6 hours
|
|
General disorders
Hypothermia
|
16.0%
8/50 • Number of events 8 • 6 hours
|
2.0%
1/50 • Number of events 1 • 6 hours
|
|
General disorders
Hyperthermia
|
6.0%
3/50 • Number of events 3 • 6 hours
|
42.0%
21/50 • Number of events 21 • 6 hours
|
|
General disorders
Viral Illness
|
0.00%
0/50 • 6 hours
|
2.0%
1/50 • Number of events 1 • 6 hours
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place