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

Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia; Long Term Oxygen Therapy; Pulse Oximeter Validation
• Intervention / Treatment: Device: OxyFrame

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Pulmonary Medicine, University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Manuela Funke, MD, Department of Pulmonary Medicine, University Hospital Bern

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: OxyFrame