Loop Band Validation Study
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|ClinicalTrials.gov Identifier: NCT03240926|
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|COPD||Device: Loop Band||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Loop Band Validation Study|
|Actual Study Start Date :||February 21, 2017|
|Actual Primary Completion Date :||January 22, 2018|
|Actual Study Completion Date :||January 25, 2018|
Experimental: Loop Band
Measure accuracy of vital sign measurements
Device: Loop Band
Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.
- Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line. [ Time Frame: 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.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: intraoperative ]Evaluate safety data based on reported Adverse Events (AEs).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240926
|United States, California|
|Huntington Memorial Hospital|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Harry Bowles, MD||Spry Health|