Pulse Oximeter ValidationOxyFrameNCT02723032
Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.
A study testing OxyFrame in people with Pulse Oximeter Validation and Long Term Oxygen Therapy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximeter Validation, Long Term Oxygen Therapy, Hypoxemia
- What is being tested?
- OxyFrame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 60 years,
- Non smoker,
- Good general health and physical fitness
- Informed Consent
- Age ≥ 18 years
- Long term oxygen therapy at rest and/or on physical effort
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- 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
Who cannot join
- 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
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- Known anemia
- Severe metabolic disease (e.g. diabetes)
- Pregnancy
- Patients
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Pulmonary Medicine, University Hospital Bern
Bern, Canton of Bern, 3010
About this study
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.
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.
Read the detailed description
Objectives:
- 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.
- 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).
- Being tested
- OxyFrame
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyFrameDevice
Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OxyFrame |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (1)
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Oximeter ValidationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Funke, MD, Principal investigator, Department of Pulmonary Medicine, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723032
- Sponsor's protocol ID
- OxyFrame
- Acronym
- OxyFrame
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02723032
- Acronym / sponsor ID
- OxyFrame / OxyFrame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects and patients | Other | Device: OxyFrameValidation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 - 60 years,
- Non smoker,
- Good general health and physical fitness
- Informed Consent
- Age ≥ 18 years
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxyFrameValidation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses. | Device | Healthy Subjects and patients |
Primary outcome
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.
1 secondary outcome
Assessment of accuracy in healthy volunteers
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Funke, MD principal investigator
Department of Pulmonary Medicine, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxyFrame in people with Pulse Oximeter Validation and Long Term Oxygen Therapy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of accuracy in patients (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.