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Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.
Secondary hypotheses include that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bair Hugger heated blanket | Active Comparator | Patients will be warmed during surgery with the Bair Hugger heated blanket. |
|
| LMA PerfecTemp system | Active Comparator | Patients will be warmed during surgery with the PerfecTemp heated pad . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heated blanket | Device | heated blanket |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average Core Temperature | Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation | from tracheal intubation to 3 hours after or tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Temperatures Above 36 Degree | Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery | at the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bair Hugger Heated Blanket | Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket |
| FG001 | LMA PerfecTemp System | Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Most baseline characteristics were well balanced be- tween the randomized groups. However, patients assigned to resistive heating were more likely to have higher ASA physical status classification. Thus, ASA status was adjusted for in all analyses. Patients in each warming group were given comparable doses of volatile anesthesia and opioid.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bair Hugger Heated Blanket | Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket |
| BG001 | LMA PerfecTemp System | Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time Weighted Average Core Temperature | Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation | Randomized patients. | Posted | Mean | Standard Deviation | Degrees C | from tracheal intubation to 3 hours after or tracheal extubation |
|
In-hospital
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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 Heated Blanket | Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler | Cleveland Clinc | 216-444-4900 | DS@OR.org |
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| heated pad | Device | patients will be warmed with a heated pad during surgery. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| preoperative oral temperature | Mean | Standard Deviation | degrees C |
|
|
|
| Secondary | Proportion of Patients With Temperatures Above 36 Degree | Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery | Enrolled patients | Posted | Count of Participants | Participants | at the end of surgery |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | LMA PerfecTemp System | Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery. | 0 | 36 | 0 | 36 |
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