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

NCT ID: NCT02723032

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Objectives:

1. 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.
2. 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).

Conditions

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Pulse Oximeter Validation Long Term Oxygen Therapy Hypoxemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

OxyFrame

Intervention Type DEVICE

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

Interventions

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OxyFrame

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuela Funke, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonary Medicine, University Hospital Bern

Locations

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Department of Pulmonary Medicine, University Hospital Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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OxyFrame

Identifier Type: -

Identifier Source: org_study_id