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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04796285

Collaborator

Cambridge Medical Technologies, LLC (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Sepsis Bacterial Lactate Blood Increase Infectious Disease	Device: Lab Clasp	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lab Clasp A finger based device to assay interstitial fluid lactate	Device: Lab Clasp Finger-based interstitial fluid assessment device

Arm

Intervention/Treatment

Experimental: Lab Clasp

A finger based device to assay interstitial fluid lactate

Device: Lab Clasp

Finger-based interstitial fluid assessment device

Outcome Measures

Primary Outcome Measures

Comparison of average difference lactate readings between Lab Clasp and laboratory reference values. [150 minutes]
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.

Secondary Outcome Measures

Measurement of participant experience [150 minutes]
We will give each participant a questionnaire when they finish their visit and will ask for their experience (Likert-type scale, 1-5)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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