Temperature Change, Body
Conditions
Keywords
Temperature management, Perioperative temperature management, Pediatric temperature management, Pediatric perioperative temperature management
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.
Interventions
DEVICEAnapod™ 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).
DEVICEBair 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).
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rectal Temperature | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Hyperthermic or Hypothermic Rescue | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 50 |
| 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). | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Anapod™ Humi-Therm Heated Humidification System | Bair Hugger™ Warming Blanket | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) White | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 29 Participants | 30 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 12 / 50 | 25 / 50 |
Outcome results
Primary
Rectal Temperature
Last measured core temperature at conclusion of the procedure (measured with rectal temperature probe) in patients assigned to the two warming systems.
Time frame: study visit 1, at conclusion of dental procedure/anesthesia administration, approximately 1-6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anapod™ Humi-Therm Heated Humidification System | Rectal Temperature | 36.7 degrees celsius | Standard Deviation 0.47 |
| Bair Hugger™ Warming Blanket | Rectal Temperature | 37.2 degrees celsius | Standard Deviation 0.38 |
Secondary
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.
Time frame: study visit 1, measured continuously throughout dental procedure/anesthesia administration, approximately 1-6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anapod™ Humi-Therm Heated Humidification System | Need for Hyperthermic or Hypothermic Rescue | 11 rescue events |
| Bair Hugger™ Warming Blanket | Need for Hyperthermic or Hypothermic Rescue | 22 rescue events |