OxyFrame: Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Completed

CT.gov ID

NCT02723032

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulse Oximeter Validation Long Term Oxygen Therapy Hypoxemia	Device: OxyFrame	N/A

Detailed Description

Objectives:

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

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 :

Mar 1, 2016

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: OxyFrame Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.

Arm

Intervention/Treatment

Other: 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.

Device: OxyFrame

Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.

Outcome Measures

Primary Outcome Measures

Assessment of accuracy in patients [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.

Secondary Outcome Measures

Assessment of accuracy in healthy volunteers [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Healthy volunteers

Inclusion Criteria:

Age 18 - 60 years,
Non smoker,
Good general health and physical fitness
Informed Consent

Exclusion Criteria:

Current or history of tobacco smoking (> 5 py)
Current alcohol or drug abuse
Heart disease or untreated arterial hypertension
Pulmonary disease
Epilepsy or other major neurologic disease
Dark skin colour
Known anemia
Severe metabolic disease (e.g. diabetes)
Pregnancy

Patients

Inclusion Criteria:

Age ≥ 18 years
Long term oxygen therapy at rest and/or on physical effort
Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or < 60 mmHg with PHT or polycythemia (men Hb > 174 g/L, women Hb > 140 g/L) or:

Oxygen desaturation on effort (SpO2 < 90%)

Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis
Informed Consent

Exclusion Criteria:

Severe hypoxemia (pO2 <40 mmHg)
Severe hypercapnia (pCO2 >55 mmHg)
Acute respiratory infection or systemic infection,
Severe systolic heart disease (LVEF < 25%)
Myocardial infarction during the last month before inclusion
Unstable angina pectoris
Severe aortic stenosis (mean gradient > 40mmHg, valve area <1 cm2)
Rhythmogenic heart disease
Severe or untreated arterial hypertension (blood pressure > 180mmHg systolic, >100mmHg diastolic)
Anemia (Hb < 120 g/l)
Known or suspected coagulation disorder (e.g. INR > 4)
Severe or untreated metabolic disorder
Neurologic disease or dementia
Pregnancy
History of non-compliance to medical treatment
Current alcohol, drug abuse or current tobacco smoking
Dark skin color

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pulmonary Medicine, University Hospital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator: Manuela Funke, MD, Department of Pulmonary Medicine, University Hospital Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT02723032

Other Study ID Numbers:

OxyFrame

First Posted:

Mar 30, 2016

Last Update Posted:

Oct 27, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Oct 27, 2016