Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes
City of Hope Medical Center
Summary
This clinical trial tests the feasibility and safety of a wearable biosensor patch for non-invasive monitoring for patients undergoing abdominal or chest surgery. Wearable biosensor patches have been developed by researchers to provide a non-invasive way to monitor substances that are normally checked using blood tests. This may reduce the need for frequent blood draws. The patches use gentle electrical stimulation to produce sweat and tiny built-in sensors to measure substances such as glucose, creatinine, and markers of inflammation, as well as oxygen and carbon dioxide levels. The wearable biosensor patch may be a feasible and safe way to monitor patients undergoing abdominal or chest surgery.
Description
PRIMARY OBJECTIVE: I. To evaluate the feasibility of data collection using wearable postoperative biosensor patch. SECONDARY OBJECTIVES: I. To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively. EXPLORATORY OBJECTIVES: I. To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector. II. To explore the accuracy of sweat-derived analyte…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days * Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use * Ability to consent to the study procedures Exclusion Criteria: * Carbachol or pilocarpine allergy * Adhesive/tape allergy * Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices * Pregnant women * Children less than 18 years of age
Interventions
- ProcedureBiospecimen Collection
Undergo sweat sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherInterview
Ancillary studies
- OtherSurvey Administration
Ancillary studies
- DeviceWearable Biosensor Patch
Wear biosensor patch
Location
- City of Hope Medical CenterDuarte, California