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

NCT02723032 | Completed DMC

• 1 other identifier: OxyFrame
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulse Oximeter Validation; Long Term Oxygen Therapy; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of accuracy in healthy volunteers

  At baseline

Study Arms (1)

Healthy Subjects and patients

OTHER

Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.

Device: OxyFrame

Interventions

OxyFrame DEVICE

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

Healthy Subjects and patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Pulmonary Medicine, University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuela Funke, MD

  Department of Pulmonary Medicine, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CH (1)