Anesthesia
Conditions
Keywords
Continuous Glucose Monitoring, Electrocautery
Brief summary
The purpose of this study is to evaluate connectivity of the FDA approved DexCom G7® continuous glucose monitor in the operating room. Continuous glucose monitors are applied to the skin and a thin sampling filament is inserted into the skin and measures blood sugar in the interstitial fluid. The DexCom G7® is used regularly outside of the operating room to monitor blood sugar, however the use of the device in the operating room environment has been limited by connectivity issues. This study will assess device connectivity at different monitoring sites.
Detailed description
This feasibility pilot study will assess connectivity of the DexCom G7® continuous glucose monitoring device (CGM) in the operating room environment at different locations on the body. The investigators believe device connectivity is affected by use of electrocautery. The monitoring sites were selected to limit electromagnetic interference from electrocautery. One cohort will have the CGM device placed on the deltoid and the electrodispersive pad placed on the thigh and the other cohort will have the CGM device placed on the thigh with the electrodispersive pad on the opposite thigh. Study personnel will note when electrocautery is used throughout the surgery and observe if the DexCom G7® continues to maintain connectivity with the receiver and provides a glucose reading. Comparing the timing of electrocautery use with connectivity to the DexCom G7® receiver provides important insight to the relationship between electrocautery and device connectivity. The CGM readings will solely be used for feasibility purposes for this study and not for determining interventions for the subjects.
Interventions
DEVICEDexcom G7® sensor placed in upper arm and positioned over deltoid
For the "subjects with Dexcom G7® sensor placed in the upper arm and positioned over the deltoid" cohort, study personnel will place the Dexcom G7® sensor on the subjects' deltoid and the electrodispursive pad on the thigh.
DEVICEDexcom G7® sensor placed in lateral thigh
For the "subjects with Dexcom G7® sensor place in lateral thigh" cohort, study personnel will place the Dexcom G7® sensor in the lateral thigh and the electrodispursive pad will be placed on the opposite thigh.
Sponsors
Loma Linda University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults age 18 and above able to consent for themselves * Willingness and ability to participate in study procedures * Surgery length estimated 3 hours or longer
Exclusion criteria
* Cardiothoracic surgical patients * Plan for intraoperative radiologic imaging * Patients on IV infusion of insulin prior to surgery * Anemia with hemoglobin less than 7 * Patients on hydroxyurea * Patients with known adhesive allergies * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of DexCom G7® sensor position on receiver connectivity during and after electrocautery use. | Change between baseline at start of procedure and completion of procedure, up to 6 hours. | Connectivity will be recorded continuously from start to finish of the procedure. The percentage of time the Dexcom G7® device remains connected during the subject's surgical case will be measured. The effect of electrocautery on CGM connectivity will be assessed by comparing the start and stop times in connectivity to the start and stop times of electrocautery. Connectivity time greater than 80% is considered highly effective. Connectivity time between 20% and 80% is considered effective. Connectivity time less than 20% is considered sub-optimal. |
Countries
United States
Contacts
STUDY_CHAIRRichard L Applegate, MD
Loma Linda University
Outcome results
None listed