Surgery
Conditions
Keywords
Plastic surgery, Warming, Core temperature, Bair Hugger, Hot Dog heating system
Brief summary
This study will test the hypothesis that an electric heating device, the Hot Dog warming system is as effective as the Bair Hugger forced air heating system.
Detailed description
Subjects undergoing major plastic surgery lasting approximately 5 hours will be randomized to either the Hot Dog resistive heating system or the Bair Hugger forced air heating system. Core temperature will be measured using a distal esophagus and mean skin temperature. Warming will continue until the subjects' core temperature reaches 37°C. Subsequent temperature will be adjusted as clinically necessary. Data will be recorded at 15 minute intervals. Core temperature will be first measured after intubation when the esophageal temperature probe is inserted. The primary outcome will be the rate of core rewarming over the range of 35°C to 37°C.
Interventions
DEVICEIntraoperative warming with Bair Hugger forced air system
Intraoperative warming with Bair Hugger forced air system
DEVICEIntraoperative warming with Hotdog resistive heating system
Intraoperative warming with Hotdog resistive heating system
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plastic surgery lasting approximately 5 hours * Subjects over the age of 18 years * Patient signed Informed Consent
Exclusion criteria
* Plastic surgery lasting less than 5 hours * Individuals under the age of 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Core Rewarming Over the Range From 35°C to 37°C. | Until the end of surgery, up to 5 hour | The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C. |
| Intraoperative Time Weighted Average Core Temperature | Until the end of surgery, up to 5 hour | Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bair Hugger Forced Air System Patients were warmed with the Bair Hugger forced air system during surgery. | 14 |
| Hot Dog Resistive Heating System Patients were warmed with the Hot Dog resistive heating system during surgery. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Bair Hugger Forced Air System | Hot Dog Resistive Heating System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment Austria | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Intraoperative Time Weighted Average Core Temperature
Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.
Time frame: Until the end of surgery, up to 5 hour
Population: Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud's disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status \> 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intra-operative Rewarming With Hot Dog | Intraoperative Time Weighted Average Core Temperature | 36.24 degrees as measured in Celcius | Standard Error 0.27 |
| Intra-operative Rewarming With Forced-air Heating | Intraoperative Time Weighted Average Core Temperature | 36.12 degrees as measured in Celcius | Standard Error 0.25 |
Comparison: Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.p-value: 0.01895% CI: [-0.37, 0.14]t-test, 1 sided
Primary
The Rate of Core Rewarming Over the Range From 35°C to 37°C.
The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.
Time frame: Until the end of surgery, up to 5 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intra-operative Rewarming With Hot Dog | The Rate of Core Rewarming Over the Range From 35°C to 37°C. | .24 degrees Celcius / hr | Standard Error 0.025 |
| Intra-operative Rewarming With Forced-air Heating | The Rate of Core Rewarming Over the Range From 35°C to 37°C. | .49 degrees Celcius / hr | Standard Error 0.027 |
Comparison: A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.p-value: 0.91t-test, 1 sided
Comparison: A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.p-value: <0.001t-test, 1 sided