Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. (OxyFrame)
26. oktober 2016 opdateret af: University Hospital Inselspital, Berne
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bern, Schweiz, 3010
- Department of Pulmonary Medicine, University Hospital Bern
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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.
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Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Assessment of accuracy in patients
Tidsramme: At baseline
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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.
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At baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of accuracy in healthy volunteers
Tidsramme: At baseline
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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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At baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Manuela Funke, MD, Department of Pulmonary Medicine, University Hospital Bern
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2016
Primær færdiggørelse (Faktiske)
1. april 2016
Studieafslutning (Faktiske)
1. maj 2016
Datoer for studieregistrering
Først indsendt
23. marts 2016
Først indsendt, der opfyldte QC-kriterier
23. marts 2016
Først opslået (Skøn)
30. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OxyFrame
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .