Temperature Change, BodyANAPODNCT03896867
Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients
A study testing Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and Bair Hugger™ Warming Blanket in people with Temperature Change, Body, run by University of Minnesota at 1 site in United States.
Trial summary
Our goal is to evaluate the efficacy of the Westmed system vs the Bair Hugger Blanket. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and Bair Hugger™ Warming Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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
Our goal is to evaluate the efficacy of the Westmed system vs the Bair Hugger Blanket.
Read the 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.
- Conditions
- Temperature Change, Body
- Being tested
- Anapod™ Humi-Therm Heated Humidification System Breathing Circuit, Bair Hugger™ Warming Blanket
- Keywords
- Temperature management, Perioperative temperature management, Pediatric temperature management, Pediatric perioperative temperature management
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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").
| Study group | Role | What they receive |
|---|---|---|
| Anapod™ Humi-Therm Heated Humidification System | Experimental | Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit. Receives: 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. Receives: Device: Bair Hugger™ Warming Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal Temperature
Last measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.
Measured: study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours
Secondary outcomes (1)
Need for Hyperthermic or Hypothermic Rescue
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.
Measured: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start31 Oct 2019
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896867
- Sponsor's protocol ID
- ANES-2019-27433
- Acronym
- ANAPOD
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2019
- Last updated
- 13 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03896867
- Acronym / sponsor ID
- ANAPOD / ANES-2019-27433
- Conditions
- Temperature Change, Body
- Keywords
- Temperature management, Perioperative temperature management, Pediatric temperature management, Pediatric perioperative temperature management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anapod™ Humi-Therm Heated Humidification System | Experimental | Device: Anapod™ Humi-Therm Heated Humidification System Breathing CircuitPatient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit. |
| Bair Hugger™ Warming Blanket | Active comparator | Device: Bair Hugger™ Warming BlanketPatient warming will be provided via the Bair Hugger™ Warming Blanket. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anapod™ Humi-Therm Heated Humidification System Breathing CircuitFor 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 | Anapod™ Humi-Therm Heated Humidification System |
| Bair Hugger™ Warming BlanketFor 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"). | Device | Bair Hugger™ Warming Blanket |
Primary outcome
Rectal Temperature
Time frame: 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.
1 secondary outcome
Need for Hyperthermic or Hypothermic Rescue
Time frame: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anapod™ Humi-Therm Heated Humidification System Breathing Circuit and Bair Hugger™ Warming Blanket in people with Temperature Change, Body, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal Temperature (time frame: study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.