Loop Band Validation Study

Study Overview
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Brief Summary
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The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.

Detailed Description
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The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to the standard method of an invasive arterial line and pressure transducer. The investigators aim to show equivalence of clinical physiologic outcome measurements with the Loop Band relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to validate this wearable technology as a potential alternative to invasive measurements, to reduce complications, and improve accuracy in regards to patient monitoring.

Official Title
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Loop Band Validation Study

Conditions
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COPD

Intervention / Treatment
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* Device: Loop Band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has capacity to consent for the study. Anesthetic plan for an arterial line for vital sign monitoring during their surgical procedure. Exclusion Criteria: Active Atrial Fibrillation Active C-difficile Amputation of the arm at the wrist or above The Investigator and/or Clinical Research Nurse will conduct a visual inspection for attributes that may diminish device accuracy. These include but are not limited to: tattoos over the radial artery, burns or heavy scarring over the radial artery, fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any condition deemed inappropriate that will preclude use of the device.

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loop Band<br>Measure accuracy of vital sign measurements | Device: Loop Band<br>* Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line. | Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate etc.) with the Loop Band relative to current methods (i.e. arterial lines, etc.) during a surgical procedure. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Evaluate safety data based on reported Adverse Events (AEs). | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, COPD Exacerbation, COPD Asthma, COPD Bronchitis, COPD, Severe Early-Onset