Safety and Usability of the LUMENA Non-invasive Ventilation Mask

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    20
  • sponsor
    Inspir Labs Ltd.
Updated on 4 October 2022
non-invasive ventilation
assisted ventilation

Summary

Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.

Description

20 participants will be included in the study. The number of patients for each group is 5.

The trial is, a crossover trial, as all participants go through every one of the trial conditions, albeit in a different order, and thus every trial condition will have results of 20 patients in it eventually.

Prior to patient treatment, the subject will be informed about the study and potential risks, and will be givin written informed consent.

Prior to every inhalation and particle sampling, a baseline sample will be taken to filter possible carryovers from previous sampling.

Demographics including age, sex, height, weight and body mass index. Past medical history including smoking status, co-morbid conditions and medication use.

Vital signs before, during and after non-invasive ventilation: heart rate, respiratory rate, blood pressure (invasive and/or non-invasive), oxygen saturation, end-tidal capnography and temperature.

Electrocardiogram (ECG) diagrams before and after use. Arterial blood gas analysis for O2, CO2, pH and HCO3 as well as serum Lactate levels before, during (every 30 mins) and after non-invasive ventilation. A maximum of 20 ml of blood will be collected from each patient.

Room aerosol particle concertation in sizes 0.3, 0.5, 1.0 and 2.5µ. Symptoms and signs during use of non-invasive ventilation (e.g. diaphoresis, anxiety).

Estimation of patient comfort (an analog 1-5 scale as well as recording of verbal comments) - the question shall be phrased thusly: In a scale of 1-5, 1 being very uncomfortable and 5 being very comfortable, how would you rate the mask you are wearing? Estimation of staff comfort (an analog 1-5 scale as well as recording of verbal comments). - the question shall be phrased thusly: In a scale of 1-5, 1 being very uncomfortable to use and 5 being very comfortable, to use how would you rate the mask? Device related AE's will be reported by number, type, seriousness, severity and duration. All device and treatment related AEs will be captured, regardless of severity.

Details
Condition Respiratory Failure
Treatment Standard NIV mask, Lumena NIV mask
Clinical Study IdentifierNCT05479773
SponsorInspir Labs Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female adults, aged 18 years and over
Suffering from hypoxemic and/or hypercarbic respiratory failure requiring non-invasive ventilation and selected by medical staff to use Mechanical NIV, CPAP or BiPAP
Fully concious (Glasgow Coma Scale 14-15) and able to cooperate with non-invasive ventilation
Able to provide informed consent to participate in the study
Have an active arterial line in place for arterial blood sampling (arterial lines will not be placed for the sole purpose of the study)

Exclusion Criteria

Age < 18 years
Pregnancy
Respiratory failure due to non-pulmonary pathology
Presence of a contraindication to the use of non-invasive ventilation or an absolute indication for invasive ventilation
Presence of a facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face
Hemodynamic instablity
Recent (< 6 months) myocardial infarction or stroke
Severe upper gastrointestinal bleeding
Chest trauma
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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