COPD
Conditions
Keywords
COPD, COPD Exacerbation, COPD Asthma, COPD Bronchitis, COPD, Severe Early-Onset
Brief summary
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
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.
Interventions
DEVICELoop Band
Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.
Sponsors
Spry Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line. | intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | intraoperative | Evaluate safety data based on reported Adverse Events (AEs). |
Countries
United States
Outcome results
None listed