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

NCT ID: NCT04796285

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-08-31

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.

Conditions

Sepsis; Sepsis Bacterial; Lactate Blood Increase; Infectious Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lab Clasp

A finger based device to assay interstitial fluid lactate

Group Type: EXPERIMENTAL

Lab Clasp

Intervention Type: DEVICE

Finger-based interstitial fluid assessment device

Interventions

Lab Clasp

Finger-based interstitial fluid assessment device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cambridge Medical Technologies, LLC

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guruprasad Jambaulikar, MBBS, MPH

Director of Research, Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guruprasad Jambaulikar, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P004159

Identifier Type: -

Identifier Source: org_study_id