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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.
This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warming Gown | Active Comparator | Comparison of two types of warming processes prior to, during, and after the surgery procedure. |
|
| Standard of Care Warming | Other | Standard of care warming with hospital-issued blankets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warming Gown | Device | Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypothermic Events | The primary outcome is the incidence of hypothermic events (core <36 degrees celsius). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarik Wasfie, MD | Ascension Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
Individual data was de-identified and not available to share on an individual level. Aggregate data was planned to shared by publishing in a scientific journal.
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Patients presenting with emergencies or with trauma were excluded.
Inpatients having surgery between September 1, 2012 through April 9, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M Bair Paws Flex Gown | 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer |
| FG001 | Control | Standard of care warm blankets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 94 subjects were included. Average age was 50.1 years. Overall, 69% were female and 90% were Caucasian. The mean core temperature in pre-op for the extended warming group was 36.8 degrees and for the control group was 36.6 degrees.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3M Bair Paws Flex Gown | 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer |
| BG001 | Control | Standard of care, warm blankets Standard of care - warm blankets |
| 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 | Incidence of Hypothermic Events | The primary outcome is the incidence of hypothermic events (core <36 degrees celsius). | Posted | Number | participants | 12 hours |
|
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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 | 3M Bair Paws Flex Gown | 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Surgeon | Genesys Regional Medical Center | 810-606-6500 | twasfie@gmail.com |
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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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Open label.
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|
| Standard of care warming | Other | The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery. |
|
| 12 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| Pulse | Mean | Standard Deviation | bpm |
|
| Temperature | Mean | Standard Deviation | Celsius |
|
| Participants |
|
|
|
| Secondary | Patient Satisfaction | Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared. | All patients completed the patient anxiety and satisfaction survey. | Posted | Number | change in percent satisfied | 12 hours |
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| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control | Standard of care warm blankets | 0 | 48 | 0 | 48 |
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