Clinical trial NCT03896867: Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temperature Change, Body
Keywords: Temperature management
Perioperative temperature management
Pediatric temperature management
Pediatric perioperative temperature management
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Rectal Temperature
timeFrame: study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours
Secondary outcomes:
measure: Need for Hyperthermic or Hypothermic Rescue
timeFrame: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: