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

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ClinicalTrials.gov Identifier: NCT02723032
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Pulse Oximeter Validation Long Term Oxygen Therapy Hypoxemia Device: OxyFrame Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Assessment of accuracy in patients [ Time Frame: 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 :
  1. Assessment of accuracy in healthy volunteers [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723032


Locations
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Switzerland
Department of Pulmonary Medicine, University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Manuela Funke, MD Department of Pulmonary Medicine, University Hospital Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02723032     History of Changes
Other Study ID Numbers: OxyFrame
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms