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Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).
Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper body blanket, Bair Hugger | Other | Patients undergoing EVAR and LEA will use this type of warming blanket. |
|
| Underbody blanket, Bair Hugger | Other | Patients undergoing EVAR and LEA will use this type of warming blanket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper body blanket, Bair Hugger | Device | Upper body warming blanket will be used in patients undergoing LEA and EVAR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket. | After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable. | Across duration of surgery (up to 210 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Age ( in Years) | The investigators will observe the profile of the patients and the mean of age in two groups. | At time of surgery ( in minutes) |
| Gender | The investigators will observe gender distribution in the two groups studied. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Upper Body Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 522 upper body blanket, Bair Hugger, 3M |
| FG001 | Underbody Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 635 full access underbody blanket, Bair Hugger, 3M |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Underbody Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 635 full access underbody blanket, Bair Hugger, 3M |
| BG001 | Upper Body Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 522 upper body blanket, Bair Hugger, 3M |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket. | After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable. | In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes) | Posted | Median | Full Range | Celsius degrees | Across duration of surgery (up to 210 minutes) |
|
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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 | Upper Body Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 522 upper body blanket, Bair Hugger, 3M |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylatic reaction | Immune system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylatic reaction | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nelson Wolosker | Hospital Israelita Albert Einstein | +55 11 2151-5423 | nwolosker@yahoo.com.br |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Underbody blanket, Bair Hugger | Device | Underbody warming blanket will be used in patients undergoing LEA and EVAR. |
|
| At time of surgery ( in minutes) |
| Type of Surgery ( LEA and EVAR ) | The investigators will observe the type of surgery distribution profile in the two groups studied. | At time of surgery ( in minutes) |
| Duration of Surgery ( in Minutes) | The investigators will observe the duration of surgery (in minutes) in the two groups studied. | Across duration of surgery ( in minutes) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Upper Body Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 522 upper body blanket, Bair Hugger, 3M |
| OG001 | Underbody Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 635 full access underbody blanket, Bair Hugger, 3M |
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| Secondary | Age ( in Years) | The investigators will observe the profile of the patients and the mean of age in two groups. | Posted | Median | Inter-Quartile Range | years | At time of surgery ( in minutes) |
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| Secondary | Gender | The investigators will observe gender distribution in the two groups studied. | Posted | Count of Participants | Participants | At time of surgery ( in minutes) |
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| Secondary | Type of Surgery ( LEA and EVAR ) | The investigators will observe the type of surgery distribution profile in the two groups studied. | Posted | Count of Participants | Participants | At time of surgery ( in minutes) |
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| Secondary | Duration of Surgery ( in Minutes) | The investigators will observe the duration of surgery (in minutes) in the two groups studied. | Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes) | Posted | Median | Inter-Quartile Range | minutes | Across duration of surgery ( in minutes) |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Underbody Blanket | Patients undergoing EVAR and LEA will use this type of warming blanket. 635 full access underbody blanket, Bair Hugger, 3M | 1 | 25 | 1 | 25 |
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