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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04796285
• Other study ID #: 2020P004159
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Are 18 years or older

2. In general good health, evidenced by no unstable medical problems (no medication changes in the past 3 months)

3. Have no known skin allergy to the components of the Lab Clasp

4. Willing to comply with all study procedures including providing venous blood samples at the CCI

5. Are English speaking

6. Provide consent to participate in the study

Exclusion Criteria:

1. Individuals <18 years old

2. General frailty of health

3. Prohibitively poor vascular access

4. History of malignancy or active malignancy

5. History of cardiac illness

6. History of HIV on antiretrovirals

7. History of alcohol abuse

8. History of uncontrolled psychiatric illness

9. Recent hospitalization within the past 30 days

10. History of vaping, propylene glycol use

11. History of statin use

12. Non-English speaking

13. Pregnant women, children, vulnerable populations

14. Investigator discretion for suspicion of poor study compliance

Related Conditions & MeSH terms

• Communicable Diseases
• Hyperlactatemia
• Infections
• Infectious Disease
• Lactate Blood Increase
• Sepsis
• Sepsis Bacterial
• Toxemia

Intervention

Device:
• Lab Clasp
Finger-based interstitial fluid assessment device

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Cambridge Medical Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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