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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Bair Hugger | Intraoperative warming with Bair Hugger forced air system |
| |
| 2: Hot Dog | Intraoperative warming with Hot Dog resistive heating system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative warming with Bair Hugger forced air system | Device | Intraoperative warming with Bair Hugger forced air system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until the end of surgery, up to 5 hour |
| 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. | Until the end of surgery, up to 5 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing major plastic surgery lasting approximately 5 hours.
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| Name | Affiliation | Role |
|---|---|---|
| Olga Plattner, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna General Hospital/University of Vienna | Vienna | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intra-operative Rewarming With Bair Hugger Heating | Intra-operative rewarming with Bair Hugger heating system |
| FG001 | Intraoperative Rewarming With Hot Dog Resistive Heating | Intraoperative rewarming with Hot Dog resistive heating system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bair Hugger Forced Air System | Patients were warmed with the Bair Hugger forced air system during surgery. |
| BG001 | Hot Dog Resistive Heating System | Patients were warmed with the Hot Dog resistive heating system during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | degrees Celcius / hr | Until the end of surgery, up to 5 hour |
|
From the beginning of the surgery until the end of surgery, up to 24 hour.
Serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bair Hugger Forced Air System | Patients were warmed with the Bair Hugger forced air system during surgery. |
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Unable to evaluate safety with small sample size. Smaller-than-expected sample size had enough power but confidence intervals for treatment effect wider than desired.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olga Plattner, Medical Doctor | Vienna General Hospital/University of Vienna | 43-1-40-400-4103 | olga.plattner@meduniwien.ac.at |
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| Intraoperative warming with Hotdog resistive heating system | Device | Intraoperative warming with Hotdog resistive heating system |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| 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. | 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. | Posted | Mean | Standard Error | degrees as measured in Celcius | Until the end of surgery, up to 5 hour |
|
|
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Hot Dog Resistive Heating System | Patients were warmed with the Hot Dog resistive heating system during surgery. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Non-Inferiority |
The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C. |