A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor

Study Overview
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Brief Summary
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The overall purpose of this study is to demonstrate the usability of a clinical-grade device in the form of a finger clasp similar to a pulse oximeter for monitoring lactate values, by comparing its performance in reading interstitial fluid lactate values against a known clinical standard in the form of venous lactate levels. Serum lactate measurements are used clinically as a measure of end-organ dysfunction and physiologic stress. Changes in lactate may indicate worsening infection in the setting of sepsis, drug toxicity for certain xenobiotics, or exercise tolerance in exercise physiology. Serum lactate cutoffs have been developed for various disease states and trigger a variety of medical decisions directed at managing the course of the disease. A common theme in the application of lactate measurements to understanding changes in physiology is the need to obtain venous blood to determine lactate. While point-of-care assays have been developed that improve the processing speed, there continues to be a need to obtain fingerstick blood or in most cases, venous blood. Obtaining venous blood for serum lactate requires an individual with phlebotomy skills, the processing capabilities of a laboratory to determine lactate concentrations, or the availability of point of care technology. An alternative method to measure lactate is to sample interstitial fluid which surrounds cells and tissues in the body. Obtaining interstitial fluid is potentially less invasive without the need for repeat phlebotomy or the presence of an indwelling intravenous catheter which can become complicated by infection. The analysis of interstitial fluid for glucose has been validated and is clinically utilized in continuous glucose monitors in individuals with diabetes. In this investigation, the investigators will utilize a novel device, the Lab Clasp to obtain interstitial fluid in a noninvasive method. The Lab Clasp is manufactured to resemble a finger pulse oximeter with additional onboard microfluidics channels that obtain a lactate concentration from interstitial fluid. This streamlined process of obtaining the point of care lactate measurements on demand allows for tasks like serial lactate measurements to be accomplished on a reliable schedule with less workload for nursing staff typically required to draw venous blood. Additionally, the portable and noninvasive nature of the Lab Clasp system may render it usable in facilities that lack skilled staff necessary to perform phlebotomy.

Official Title
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A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor

Conditions
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Sepsis, Sepsis Bacterial, Lactate Blood Increase, Infectious Disease

Intervention / Treatment
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* Device: Lab Clasp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Are 18 years or older In general good health, evidenced by no unstable medical problems (no medication changes in the past 3 months) Have no known skin allergy to the components of the Lab Clasp Willing to comply with all study procedures including providing venous blood samples at the CCI Are English speaking Provide consent to participate in the study Exclusion Criteria: Individuals <18 years old General frailty of health Prohibitively poor vascular access History of malignancy or active malignancy History of cardiac illness History of HIV on antiretrovirals History of alcohol abuse History of uncontrolled psychiatric illness Recent hospitalization within the past 30 days History of vaping, propylene glycol use History of statin use Non-English speaking Pregnant women, children, vulnerable populations Investigator discretion for suspicion of poor study compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lab Clasp<br>A finger based device to assay interstitial fluid lactate | Device: Lab Clasp<br>* Finger-based interstitial fluid assessment device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of average difference lactate readings between Lab Clasp and laboratory reference values. | The primary outcome measure will be the average difference in lactate values between the Lab Clasp device and the reference (laboratory venous lactate) in healthy volunteers. We will obtain multiple (nine timepoints in total) investigational-reference measurement pairs in each subject (150 minutes total) and will average the difference over all pairs from all subjects. | 150 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of participant experience | We will give each participant a questionnaire when they finish their visit and will ask for their experience (Likert-type scale, 1-5) | 150 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactate, point of care, sepsis, interstitial fluid