Safety and Usability of the LUMENA Non-invasive Ventilation Mask

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

Detailed Description
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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, DOB, 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, Tidal volume, oxygen saturation, Mode of ventilation, peak inspiratory pressure, pressure support, Ventilator type and model, Trigger sensitivity, Fio 2%, PEEP, blood pressure (invasive and/or non-invasive) and temperature. Electrocardiogram (ECG) diagrams before and after use. Arterial blood\ Venous blood gas analysis for O2, CO2, pH and HCO3 as well as serum Lactate levels before, during 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 preference of the mask - the question shall be phrased thusly: In a Which mask do you prefer? 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? Estimation of staff use - the question shall be phrased thusly: Which mask do you prefer? Estimation of patient comfort - the question will be directed to the staff member. (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 patient's feeling with the experimental 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.

Official Title
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Safety and Usability of the LUMENA Non-invasive Ventilation Mask

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Standard NIV mask
* Device: Lumena NIV mask


Participation Criteria
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Eligibility Criteria
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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 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). Alternatively, IV line can be used. 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. Severe upper gastrointestinal bleeding. Chest trauma. Claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Treatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction. | Device: Standard NIV mask<br>* The hospital standered NIV mask<br>Device: Lumena NIV mask<br>* aerosol-reducing mask<br>|
| Other: Group B<br>Treatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction. | Device: Standard NIV mask<br>* The hospital standered NIV mask<br>Device: Lumena NIV mask<br>* aerosol-reducing mask<br>|
| Other: Group C<br>Treatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask. | Device: Standard NIV mask<br>* The hospital standered NIV mask<br>Device: Lumena NIV mask<br>* aerosol-reducing mask<br>|
| Other: Group D<br>Treatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask. | Device: Standard NIV mask<br>* The hospital standered NIV mask<br>Device: Lumena NIV mask<br>* aerosol-reducing mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPO2 | Precentage of SPO2 before ventilation | During the 30 minutes before starting the ventilation | 
| SPO2 | Precentage of SPO2 during ventilation | Every 20 minutes during ventilation | 
| SPO2 | Precentage of SPO2 post ventilation | Up to 30 minutes post ventilation | 
| pO2 | mmHg of PO2 before ventilation | During the 30 minutes before starting the ventilation | 
| pO2 | mmHg of PO2 during ventilation and post ventilation | Every 20 minutes during ventilation | 
| pO2 | mmHg of PO2 post ventilation | Up to 30 minutes post ventilation | 
| pCO2 | pCO2 before ventilation measured in mmHg | During the 30 minutes before starting the ventilation | 
| pCO2 | pCO2 during ventilation measured in mmHg | Every 20 minutes during ventilation | 
| pCO2 | pCO2 post ventilation measured in mmHg | Up to 30 minutes post ventilation | 
| pH | logarithmic units of pH before ventilation | During the 30 minutes before starting the ventilation | 
| pH | logarithmic units of pH during ventilation | Every 20 minutes during ventilation | 
| pH | logarithmic units of pH post ventilation | Up to 30 minutes post ventilation | 
| HCO3 | HCO3 before ventilation measured in mEq/L | During the 30 minutes before starting the ventilation | 
| HCO3 | HCO3 during ventilation measured in mEq/L | Every 20 minutes during ventilation | 
| HCO3 | HCO3 post ventilation measured in mEq/L | Up to 30 minutes post ventilation | 
| Serum Lactate | Serum Lactate before ventilation measured in mmol/Lit | During the 30 minutes before starting the ventilation | 
| Serum Lactate | Serum Lactate during ventilation measured in mmol/Lit | Every 20 minutes during ventilation | 
| Serum Lactate | Serum Lactate post ventilation measured in mmol/Lit | Up to 30 minutes post ventilation | 
| Respiratory Rate | Measuring of Respiratory Rate in breaths per minute, during ventilation | during ventilation | 
| Adverse Events | Number of patients related Adverse Events as assessed by CTCAE v5.0 | From date of study randomization until the end of treatment per each patient, up to 30 min post ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Room aerosol concentration | Room aerosol concentration during usage of the Lumena for particle 0.3, 0.5, 1.0 and 2.5 Microns in units of parts per cubic meter of air | Before ventilation and during ventilation | 
| Use comfort | Patient assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest. | Up up 1 hour post ventilation | 
| Use comfort | Staff member assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest. | Up up 1 hour post ventilation |