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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896867
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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

Condition or disease Intervention/treatment Phase
Temperature Change, Body Device: Anapod™ Humi-Therm Heated Humidification System Breathing Circuit Device: Bair Hugger™ Warming Blanket Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
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
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Arm Intervention/treatment
Experimental: Anapod™ Humi-Therm Heated Humidification System
Patient warming will be provided via the Anapod™ Humi-Therm Heated Humidification System Breathing Circuit.
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").

Active Comparator: Bair Hugger™ Warming Blanket
Patient warming will be provided via the Bair Hugger™ Warming Blanket.
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").




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Need for Hyperthermic or Hypothermic Rescue [ Time Frame: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours ]
    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.

  2. Cumulative degree-minutes above and below 37C [ Time Frame: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours ]
    Two temperature recording devices will be used: 3M SpotOn™ Forehead Temperature probe, (used routinely in the operating rooms and postoperative recovery areas) and a standard rectal thermistor probe. Cumulative minutes that patients spend above or below 37C will be compared between groups. A larger sum of degree-minutes above and below 37C indicates worse performance for that temperature control method.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896867


Contacts
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Contact: Benjamin Kloesel, MD 612-625-6659 bkloesel1@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Benjamin Kloesel    612-626-3284    bkloesel@umn.edu   
Sponsors and Collaborators
University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03896867    
Other Study ID Numbers: STUDY00005616
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota:
Temperature management
Perioperative temperature management
Pediatric temperature management
Pediatric perioperative temperature management
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms