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

Not Applicable

Completed

• Conditions: Hypoxemia; Pulse Oximeter Validation; Long Term Oxygen Therapy
• Interventions: Device: OxyFrame

• Registration Number: NCT02723032
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects and patients	OxyFrame	Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Pulmonary Medicine, University Hospital Bern; 🇨🇭 Bern, Switzerland