Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. (OxyFrame)
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|ClinicalTrials.gov Identifier: NCT02723032|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulse Oximeter Validation Long Term Oxygen Therapy Hypoxemia||Device: OxyFrame||Not Applicable|
- To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation.
- To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
Healthy Subjects and patients
Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.
Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.
- Assessment of accuracy in patients [ Time Frame: At baseline ]Assessment of the accuracy of the novel pulse oximeter sensor in patients qualifying for LTOT over the entire saturation range by calculating accuracy root mean square (ARMS). Continuous SpO2 measurement of the novel pulse oximeter will be compared to measurements assessed by 2 standard pulse oximeters and arterial blood gas analysis.
- Assessment of accuracy in healthy volunteers [ Time Frame: At baseline ]Assessment of accuracy of the novel pulse oximeter sensor in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation. SpO2 will be measured continuously over the hole procedure and SpO2 range by the novel pulse oximeter sensor and the 2 reference pulse oximeters.
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): NCT02723032
|Department of Pulmonary Medicine, University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Manuela Funke, MD||Department of Pulmonary Medicine, University Hospital Bern|