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Trial record 29 of 619 for:    oximeter

Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer (EOXY)

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ClinicalTrials.gov Identifier: NCT03614416
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
NAMSA
Université Catholique de Louvain
Information provided by (Responsible Party):
BioSerenity

Brief Summary:

The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY.

Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.


Condition or disease Intervention/treatment Phase
Healthy Device: EOXY device Device: Gold standard oximeter Procedure: SaO2 sampling Not Applicable

Detailed Description:

The primary objective is to evaluate and document the SpO2 accuracy of the pulse oximeter equipment, evaluating the performance of the device compared to invasive method blood sampling (SaO2) by CO-Oximeter in healthy subjects during invasive controlled desaturation study at different ranges (100 % to 70% SaO2).

Subject safety during desaturation and saturation period, will be evaluated by reviewing vital sign: heart rate (HR) continuously and blood pressure/temperature between each desaturation plateau.

There are two secondaries objectives, the measurement of the variation of the fraction of inspired oxygen (FiO2), and the validation of the algorithm for data review and analysis.

For the study primary phase, the purpose of this phase is to test the body area where the SpO2 is better detected and define 3 measurement areas. For this, three healthy volunteers will be placed in normal O2 saturation, the SpO2 will be measured using the Bioserenity oximeter (noninvasive method) and will be compared to a gold-standard oximeter CE-marked. The investigator will determine the best area in the body where the SpO2 could be taken for the following subjects.

During a second phase, the measurement of Sp02 and HR with EOXY, will be performed in O2 saturation conditions up to 100% and then in desaturation by plateau from 100 % to 70%. 3 EOXY pulse oximeter recorded the SpO2 at the same time in 3 different areas of the body. As required by the standard, Sp02 measures will be simultaneously compared to SaO2 values measured by blood sampling taken from an indwelling arterial catheter. The HR obtained with EOXY will be compared simultaneously to a gold standard oximeter CE-marked.

As the example in the standard, it was choosen to do the test on the 70-100% range, with 5 plateaus (100%-97%, 97%-92%, 92%-85%, 84%-78%, 77%-70%) and to collect five Sp02 and Sa02 values (blood samples) and five HR measures, per plateau, for each of 13 subjects.

The desaturation will be controlled thanks' the FiO2 measures, that should allow to bring subjects near target levels of desaturation plateau.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: No randomisation. All subjects will test simultaneously the gold standard and the EOXY device
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : November 6, 2018

Arm Intervention/treatment
Experimental: EOXY device and Gold standard oximter and SaO2 measures
Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter
Device: EOXY device
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

Device: Gold standard oximeter
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

Procedure: SaO2 sampling
Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard




Primary Outcome Measures :
  1. SpO2 EOXY measures [ Time Frame: 4 hours ]
    At each desaturation plateau, five SpO2 values from the EOXY device are noted. (simultaneously with heart rate EOXY measures, and with heart rate gold standard measures, and with SaO2 blood sampling measures)

  2. Heart rate EOXY measures [ Time Frame: 4 hours ]
    At each desaturation plateau, five heart rate values from the EOXY device are noted

  3. SaO2 blood sampling measures [ Time Frame: 4 hours ]
    At each desaturation plateau, five SaO2 values from the blood sampling are noted At each desaturation plateau, five SpO2 values from the EOXY device are noted. (simultaneously with heart rate EOXY measures, and with heart rate gold standard measures, and with SaO2 blood sampling measures)

  4. Heart rate gold standard measures [ Time Frame: 4 hours ]
    At each desaturation plateau, five heart rate values from the gold standard oximeter At each desaturation plateau, five SpO2 values from the EOXY device are noted. (simultaneously with heart rate EOXY measures, and with heart rate gold standard measures, and with SaO2 blood sampling measures)device are noted



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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

Inclusion Criteria:

  • Healthy subject (Man/ Women) > 18 years old
  • Subject signed informed consent prior to any screening procedure
  • Subject in good health (COHb < 3% , MetHb < 2%, CtHb > 10mg/dL)
  • Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk

Exclusion Criteria:

  • Smokers or individuals exposed to high levels of carbon monoxide that result in elevation of carboxy hemoglobin levels
  • Individual subject to conditions that result in elevated levels of methemoglobin
  • Subject who would be placed at undue medical risk associated with any procedure called for in the protocol
  • Subject with open wounds
  • Pregnant woman (negative pregnancy test needed)
  • Subject allergic to silicon, polyamide and silver yarn
  • Subject with cardiorespiratory disorders likely to worsen with thoracic pressure applied by the textile band
  • Subject with mental or motor impairment preventing him from expressing pain
  • Subject with blood or skin disorder that may impacting results
  • Subject with behavioral disorders, too agitated or too aggressive
  • Subject with sensorial disorders, insensible to skin pain
  • Subject susceptible to tension/pressure based headaches

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): NCT03614416


Locations
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Belgium
Université catholique louvain la neuve, centre sportif
Louvain-la-Neuve, Belgium, 1348
Sponsors and Collaborators
BioSerenity
NAMSA
Université Catholique de Louvain
Investigators
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Principal Investigator: marc FRANCAUX UNIVERSITE CATHOLIQUE DE LOUVAIN

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Responsible Party: BioSerenity
ClinicalTrials.gov Identifier: NCT03614416     History of Changes
Other Study ID Numbers: BIOSERENITY_80601-2-61
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No