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Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.
We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Other | Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. |
|
| Regional anesthesia | Other | Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Draeger double-sensor | Device | The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin. |
| Measure | Description | Time Frame |
|---|---|---|
| The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group. | From anesthesia induction to the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for Detection of Hypothermia | Hypothermia is defined as a temperature < 36 Celsius degree | From anesthesia induction to the end of surgery |
| Specificity for Detection of Hypothermia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Kurz, M.D. | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, M.D. | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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Patients having trauma surgery with general anesthesia were recruited from the University of Vienna, while patients having orthopedic surgery with regional anesthesia were recruited from the Cleveland Clinic from January 2009 to June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | General Anesthesia | Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. |
| FG001 | Regional Anesthesia | Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | General Anesthesia | Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. |
| BG001 | Regional Anesthesia |
| 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 | The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group. | Posted | Mean | 95% Confidence Interval | Celsius degree | From anesthesia induction to the end of surgery |
|
through study completion, an average of 3 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 | General Anesthesia | Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Kurz | Cleveland Clinic | 216 445-9924 | KURZA@ccf.org |
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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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| Esophageal stethoscope temperature sensor | Device | Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery. |
|
| Foley catheter temperature sensor | Device | Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery |
|
Hypothermia will be defined as a temperature < 36 Celsius degree
| From anesthesia induction to the end of surgery |
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ambient temperature | Mean | Standard Deviation | Celsius degree |
|
| Duration of surgery | Median | Inter-Quartile Range | hours |
|
|
|
| Secondary | Sensitivity for Detection of Hypothermia | Hypothermia is defined as a temperature < 36 Celsius degree | Posted | Number | 95% Confidence Interval | percent of hypothermias | From anesthesia induction to the end of surgery |
|
|
|
| Secondary | Specificity for Detection of Hypothermia | Hypothermia will be defined as a temperature < 36 Celsius degree | Posted | Number | 95% Confidence Interval | percent of non-hypothermias | From anesthesia induction to the end of surgery |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Regional Anesthesia | Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. | 0 | 20 | 0 | 20 | 0 | 20 |
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