Healthy
Conditions
Keywords
High intensity exercise, Stress Testing
Brief summary
The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].
Interventions
DEVICELabClasp
Non-invasive device that estimates blood \[lactate\] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood \[lactate\] and return a value to the subject via an accompanying tablet within 20 seconds.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Aim 1: * Subjects must be able to provide written consent. * Adults 18 years of age and older. * Nonsmokers. * No recent hospitalization (\< 60 days). * Ability to perform high-intensity exercise. Inclusion Criteria - Aim 2: * Subjects must be able to provide written consent to be included in the research study. * Adults 18 years of age and older. * Nonsmokers. * Current ICU patient. * Have regular blood samples taken for \[lactate\] measurements. * Have one or more risk factors for sepsis.
Exclusion criteria
- Aims 1 and 2: * History of, or active malignancy. * History of HIV with antiretroviral treatment. * Smokers. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood [lactate] during incremental exercise | 1 day | Measured via venous blood and the LabClasp |
| Blood [lactate] measurements in ICU patients | 1 day | Measured via venous blood and the LabClasp |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirend Somers
Mayo Clinic
Outcome results
None listed