Hypothermia
Conditions
Keywords
forced-air warming, hypothermia, endovascular surgery, blanket
Brief summary
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).
Detailed description
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.
Interventions
DEVICEUpper body blanket, Bair Hugger
Upper body warming blanket will be used in patients undergoing LEA and EVAR.
DEVICEUnderbody blanket, Bair Hugger
Underbody warming blanket will be used in patients undergoing LEA and EVAR.
Sponsors
Nelson Wolosker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing LEA and EVAR * American Society of Anesthesiologists physical status (ASA) : 1-4
Exclusion criteria
* Non-endovascular surgery * pregnant patients * patient refusal * less than 45 minutes duration of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Across duration of surgery (up to 210 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age ( in Years) | At time of surgery ( in minutes) | The investigators will observe the profile of the patients and the mean of age in two groups. |
| Gender | At time of surgery ( in minutes) | The investigators will observe gender distribution in the two groups studied. |
| Type of Surgery ( LEA and EVAR ) | At time of surgery ( in minutes) | The investigators will observe the type of surgery distribution profile in the two groups studied. |
| Duration of Surgery ( in Minutes) | Across duration of surgery ( in minutes) | The investigators will observe the duration of surgery (in minutes) in the two groups studied. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Underbody Blanket Patients undergoing EVAR and LEA will use this type of warming blanket.
635 full access underbody blanket, Bair Hugger, 3M | 23 |
| Upper Body Blanket Patients undergoing EVAR and LEA will use this type of warming blanket.
522 upper body blanket, Bair Hugger, 3M | 25 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Underbody Blanket | Upper Body Blanket | Total |
|---|---|---|---|
| Age, Continuous | 71 years | 70 years | 70.5 years |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
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.
Time frame: Across duration of surgery (up to 210 minutes)
Population: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Upper Body Blanket | 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. | 36.2 Celsius degrees |
| Underbody Blanket | 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. | 36.1 Celsius degrees |
p-value: 0.19Generalized Estimation Equations (GEE)
Secondary
Age ( in Years)
The investigators will observe the profile of the patients and the mean of age in two groups.
Time frame: At time of surgery ( in minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Upper Body Blanket | Age ( in Years) | 70 years |
| Underbody Blanket | Age ( in Years) | 71 years |
p-value: 0.82Wilcoxon (Mann-Whitney)
Secondary
Duration of Surgery ( in Minutes)
The investigators will observe the duration of surgery (in minutes) in the two groups studied.
Time frame: Across duration of surgery ( in minutes)
Population: Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Upper Body Blanket | Duration of Surgery ( in Minutes) | 180 minutes |
| Underbody Blanket | Duration of Surgery ( in Minutes) | 210 minutes |
p-value: 0.462Wilcoxon (Mann-Whitney)
Secondary
Gender
The investigators will observe gender distribution in the two groups studied.
Time frame: At time of surgery ( in minutes)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Upper Body Blanket | Gender | Female | 8 Participants |
| Upper Body Blanket | Gender | Male | 15 Participants |
| Underbody Blanket | Gender | Female | 6 Participants |
| Underbody Blanket | Gender | Male | 19 Participants |
p-value: 0.529Chi-squared
Secondary
Type of Surgery ( LEA and EVAR )
The investigators will observe the type of surgery distribution profile in the two groups studied.
Time frame: At time of surgery ( in minutes)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Upper Body Blanket | Type of Surgery ( LEA and EVAR ) | EVAR | 13 Participants |
| Upper Body Blanket | Type of Surgery ( LEA and EVAR ) | LEA | 12 Participants |
| Underbody Blanket | Type of Surgery ( LEA and EVAR ) | EVAR | 12 Participants |
| Underbody Blanket | Type of Surgery ( LEA and EVAR ) | LEA | 11 Participants |
p-value: 0.999Chi-squared