Hypothermia
Conditions
Keywords
orthopaedics, post-operative warming
Brief summary
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.
Detailed description
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group. In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping. In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table. Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.
Interventions
DEVICEBair Hugger
DEVICEVitaHeat
Sponsors
Fox Valley Orthopedic Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing orthopaedic outpatient surgeries over 18 years old
Exclusion criteria
* allergic to material of bair hugger
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | Intra-Operative | Measured by temporal artery thermometer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Forced Air Bair Hugger
Bair Hugger | 23 |
| Conductive Warming VitaHeat
VitaHeat | 27 |
| Total | 50 |
Baseline characteristics
| Characteristic | Conductive Warming | Forced Air | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 39 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 16.15 | 53 years STANDARD_DEVIATION 11.52 | 51.6 years STANDARD_DEVIATION 14.41 |
| Region of Enrollment United States | 27 participants | 23 participants | 50 participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 27 |
| other Total, other adverse events | 0 / 23 | 0 / 27 |
| serious Total, serious adverse events | 0 / 23 | 0 / 27 |
Outcome results
Primary
Temperature
Measured by temporal artery thermometer
Time frame: Intra-Operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forced Air | Temperature | 97.95 degrees celsius | Standard Deviation 0.6 |
| Conductive Warming | Temperature | 97.64 degrees celsius | Standard Deviation 0.58 |