Estimating Blood [Lactate] Non-Invasively

Study Overview
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Brief Summary
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The purpose of this study is to validate the LabClasp's ability to estimate blood [lactate].

Official Title
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Validation of a Non-Invasive Instrument to Estimate Blood Lactate

Conditions
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Healthy

Intervention / Treatment
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* Device: LabClasp


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-body exercise in healthy adults (Aim 1)<br>Subjects will have blood [lactate] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle. | Device: LabClasp<br>* 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.<br>|
| Experimental: ICU patients susceptible to developing sepsis (Aim 2)<br>Subjects will have blood [lactate] measurement obtained with the LabClasp device as frequently as required for clinical purposes | Device: LabClasp<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood [lactate] during incremental exercise | Measured via venous blood and the LabClasp | 1 day | 
| Blood [lactate] measurements in ICU patients | Measured via venous blood and the LabClasp | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High intensity exercise, Stress Testing