A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo sweat sample collection
Electronic Health Record Review
Other interventionAncillary studies
Interview
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Wearable Biosensor Patch
DeviceWear biosensor patch
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Diagnostic (wearable biosensor patch)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Proportion of successful sweat collections (feasibility)
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.
Time frame
Up to 1 yearSecondary outcomes
1
Acceptability of the intervention
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.
Time frame
Up to 1 year2
Incidence of treatment related adverse events related to biosensor use
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.
Time frame
Up to 1 year3
Processes and resources needed to deploy the wearable biosensor patches postoperatively
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.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: