Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief 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.
Detailed 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 concentrations relative to peripheral blood measurements (gold standard). III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂). IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard). OUTLINE: Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon dioxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively. After completion of study intervention, patients may be followed up for up to 1 year.
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
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of successful sweat collections (feasibility) | Up to 1 year | A successful collection will be defined by patch application with data successfully recorded and sent to the database. Examples of failed collections include, but are not limited to, a patch falling off before data collection can occur or a patch failing to collect and send data to the database. The number of successful collections will be reported as a proportion of the total number of attempted applications. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. Given the small sample, two-sided 95 percent exact (Clopper-Pearson) confidence intervals will be provided for proportions. In addition to the overall success rate, the success rates for each type of patch (intraoperative and postoperative) will be described. All causes of failure (including unknown causes) will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention | Up to 1 year | Assessed using Acceptability of Intervention Measure (AIM) scores and qualitative data analysis of patient exit interviews. Scores will be summarized descriptively. Exit interviews will be conducted to explore subjective experience with the biosensor patch. Topics will include comfort/discomfort while wearing the patch, comfort/discomfort during application and removal, and open-ended feedback. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. |
| Incidence of treatment related adverse events related to biosensor use | Up to 1 year | Safety will be evaluated based on the incidence of treatment-emergent adverse events deemed definitely, probably, or possibly related to the biosensor device. Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. |
| Processes and resources needed to deploy the wearable biosensor patches postoperatively | Up to 1 year | Processes and resources needed to deploy the biosensor patches will be assessed through one focus group. Topics will include: approximate time to setting up the patch for patients and applying them, barriers and facilitators in deploying the patches, and open-ended feedback. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKelly Mahuron
City of Hope Medical Center
Outcome results
None listed