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The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open colectomy under general anesthesia. This is a randomized study.
Participants will be randomized into one of two groups. Patients assigned to vitalHEAT warming will have the circulating-water sleeve applied to an arm that will not require intravenous access. An esophageal temperature probe will be inserted and connected to the anesthesia machine monitoring system. Intravenous fluids will be warmed to 40-42°C.
As soon as practical after induction, the vitalHEAT warmer will be activated in the appropriate patients and set to "high" which is 42°C
An upper-body forced-air warmer will be positioned over the upper body and exposed arms on patients assigned to forced-air heating. The forced air blower will be set to "high" which is 43°C and activated as soon as practical, usually after prepping and draping.
Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Active warming will be maintained until just before extubation. The esophageal temperature probe will be removed, and the patient extubated after emergence from anesthesia. This will conclude the study and subsequent management will be at the discretion of the attending anesthesiologist
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vital Heat | Active Comparator | Vital HEAT (vH2) Temperature Management System |
|
| Forced air | Active Comparator | Forced-air warming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a forced-air warming cover | Device | A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Distal Esophageal (Core) Temperature | at 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Warm-water Sleeve | The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends. vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery. |
| FG001 | Forced Air | Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed. a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 patients with missing data, including 3 in the warm-water sleeve group and 2 in the forced air group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Warm-water Sleeve | The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends. vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after 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 | Intraoperative Distal Esophageal (Core) Temperature | Posted | Mean | Standard Error | °C | at 1 hour |
|
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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 | Warm-water Sleeve | The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends. vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler | Cleveland Clinic Foundation | 216-444-4900 | DS@OR.org |
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| vital HEAT (vH2) Temperature Management System | Device | The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery. |
|
| BG001 | Forced Air | Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed. a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Forced Air | Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed. a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery. | 0 | 34 | 0 | 34 |
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