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By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects and patients | Other | Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyFrame | Device | Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of accuracy in patients | 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. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of accuracy in healthy volunteers | 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. | At baseline |
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Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
Patients
Inclusion Criteria:
Oxygen desaturation on effort (SpO2 < 90%)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuela Funke, MD | Department of Pulmonary Medicine, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonary Medicine, University Hospital Bern | Bern | Canton of Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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