Hypothermia; Anesthesia
Conditions
Keywords
surgery, thermometer, non-invasive, interoperative core temperature, anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDraeger double-sensor
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.
DEVICEEsophageal stethoscope temperature sensor
Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.
DEVICEFoley catheter temperature sensor
Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing trauma surgery with general anesthesia * Patients undergoing orthopedic surgery with regional anesthesia
Exclusion criteria
* Younger than 18 or older than 80 years of age * Have a pre-existing nasogastric tube * Require bispectral index monitoring * Upper esophageal disease * Forehead rash or infection * Oral infection or trauma * Ear infection or drainage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | From anesthesia induction to the end of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for Detection of Hypothermia | From anesthesia induction to the end of surgery | Hypothermia is defined as a temperature \< 36 Celsius degree |
| Specificity for Detection of Hypothermia | From anesthesia induction to the end of surgery | Hypothermia will be defined as a temperature \< 36 Celsius degree |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| General Anesthesia Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. | 36 |
| Regional Anesthesia Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. | 20 |
| Total | 56 |
Baseline characteristics
| Characteristic | Regional Anesthesia | Total | General Anesthesia |
|---|---|---|---|
| Age, Continuous | 65 years | 64 years | 64 years |
| Ambient temperature | 19.5 Celsius degree STANDARD_DEVIATION 1 | 19.4 Celsius degree STANDARD_DEVIATION 1.1 | 19.2 Celsius degree STANDARD_DEVIATION 1.2 |
| Duration of surgery | 1.2 hours | 1.8 hours | 2.0 hours |
| Region of Enrollment Austria | 0 participants | 36 participants | 36 participants |
| Region of Enrollment United States | 20 participants | 20 participants | 0 participants |
| Sex: Female, Male Female | 13 Participants | 35 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 21 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 20 |
| other Total, other adverse events | 0 / 36 | 0 / 20 |
| serious Total, serious adverse events | 0 / 36 | 0 / 20 |
Outcome results
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.
Time frame: From anesthesia induction to the end of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| General Anesthesia | The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | -0.01 Celsius degree |
| Regional Anesthesia | The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | -0.13 Celsius degree |
Secondary
Sensitivity for Detection of Hypothermia
Hypothermia is defined as a temperature \< 36 Celsius degree
Time frame: From anesthesia induction to the end of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Anesthesia | Sensitivity for Detection of Hypothermia | 0.70 percent of hypothermias |
| Regional Anesthesia | Sensitivity for Detection of Hypothermia | 0.83 percent of hypothermias |
Secondary
Specificity for Detection of Hypothermia
Hypothermia will be defined as a temperature \< 36 Celsius degree
Time frame: From anesthesia induction to the end of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Anesthesia | Specificity for Detection of Hypothermia | 0.78 percent of non-hypothermias |
| Regional Anesthesia | Specificity for Detection of Hypothermia | 0.69 percent of non-hypothermias |