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

Hypoxemia Clinical Trial

— OxyFrame  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723032
• Other study ID #: OxyFrame
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: October 26, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anoxia
• Hypoxemia
• Long Term Oxygen Therapy
• Pulse Oximeter Validation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Pulmonary Medicine, University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No