An interventional study of Standard NIV mask and Lumena NIV mask in Respiratory Failure, sponsored by Inspir Labs Ltd.. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Inspir Labs Ltd. · Not applicable, Interventional, and Prevention
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 20 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →This is the only study on the registry with Inspir Labs Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction.
Device: Standard NIV mask · Device: Lumena NIV mask
Treatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction.
Device: Standard NIV mask · Device: Lumena NIV mask
Treatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask.
Device: Standard NIV mask · Device: Lumena NIV mask
Treatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask.
Device: Standard NIV mask · Device: Lumena NIV mask
The hospital standered NIV mask
aerosol-reducing mask
SPO2
Precentage of SPO2 before ventilation
Time frame: During the 30 minutes before starting the ventilation
SPO2
Precentage of SPO2 during ventilation
Time frame: Every 20 minutes during ventilation
SPO2
Precentage of SPO2 post ventilation
Time frame: Up to 30 minutes post ventilation
pO2
mmHg of PO2 before ventilation
Time frame: During the 30 minutes before starting the ventilation
pO2
mmHg of PO2 during ventilation and post ventilation
Time frame: Every 20 minutes during ventilation
pO2
mmHg of PO2 post ventilation
Time frame: Up to 30 minutes post ventilation
pCO2
pCO2 before ventilation measured in mmHg
Time frame: During the 30 minutes before starting the ventilation
pCO2
pCO2 during ventilation measured in mmHg
Time frame: Every 20 minutes during ventilation
pCO2
pCO2 post ventilation measured in mmHg
Time frame: Up to 30 minutes post ventilation
pH
logarithmic units of pH before ventilation
Time frame: During the 30 minutes before starting the ventilation
pH
logarithmic units of pH during ventilation
Time frame: Every 20 minutes during ventilation
pH
logarithmic units of pH post ventilation
Time frame: Up to 30 minutes post ventilation
HCO3
HCO3 before ventilation measured in mEq/L
Time frame: During the 30 minutes before starting the ventilation
HCO3
HCO3 during ventilation measured in mEq/L
Time frame: Every 20 minutes during ventilation
HCO3
HCO3 post ventilation measured in mEq/L
Time frame: Up to 30 minutes post ventilation
Serum Lactate
Serum Lactate before ventilation measured in mmol/Lit
Time frame: During the 30 minutes before starting the ventilation
Serum Lactate
Serum Lactate during ventilation measured in mmol/Lit
Time frame: Every 20 minutes during ventilation
Serum Lactate
Serum Lactate post ventilation measured in mmol/Lit
Time frame: Up to 30 minutes post ventilation
Respiratory Rate
Measuring of Respiratory Rate in breaths per minute, during ventilation
Time frame: during ventilation
Adverse Events
Number of patients related Adverse Events as assessed by CTCAE v5.0
Time frame: From date of study randomization until the end of treatment per each patient, up to 30 min post ventilation
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
Time frame: 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.
Time frame: 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.
Time frame: Up up 1 hour post ventilation
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