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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loop Band | Experimental | Measure accuracy of vital sign measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop Band | Device | Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Evaluate safety data based on reported Adverse Events (AEs). | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Bowles, MD | Spry Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Memorial Hospital | Pasadena | California | 91105 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| C564641 | Pulmonary Disease, Chronic Obstructive, Severe Early-Onset |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |