Clinical trial NCT05479773: Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Official title: Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Inspir Labs Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed 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, 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female adults, aged 18 years and over.
2. Suffering from hypoxemic and/or hypercarbic respiratory failure requiring non-invasive ventilation and selected by medical staff to use CPAP or BiPAP.
3. Fully concious (Glasgow Coma Scale 14-15) and able to cooperate with non-invasive ventilation.
4. Able to provide informed consent to participate in the study.
5. 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:

1. Age \< 18 years.
2. Pregnancy.
3. Respiratory failure due to non-pulmonary pathology.
4. Presence of a contraindication to the use of non-invasive ventilation or an absolute indication for invasive ventilation.
5. Presence of a facial deformity, heavy beard or moustache which prevents a good seal between the mask and the face.
6. Hemodynamic instablity.
7. Severe upper gastrointestinal bleeding.
8. Chest trauma.
9. Claustrophobia

Primary outcomes:
measure: SPO2
timeFrame: During the 30 minutes before starting the ventilation
measure: SPO2
timeFrame: Every 20 minutes during ventilation
measure: SPO2
timeFrame: Up to 30 minutes post ventilation
measure: pO2
timeFrame: During the 30 minutes before starting the ventilation
measure: pO2
timeFrame: Every 20 minutes during ventilation
measure: pO2
timeFrame: Up to 30 minutes post ventilation
measure: pCO2
timeFrame: During the 30 minutes before starting the ventilation
measure: pCO2
timeFrame: Every 20 minutes during ventilation
measure: pCO2
timeFrame: Up to 30 minutes post ventilation
measure: pH
timeFrame: During the 30 minutes before starting the ventilation
measure: pH
timeFrame: Every 20 minutes during ventilation
measure: pH
timeFrame: Up to 30 minutes post ventilation
measure: HCO3
timeFrame: During the 30 minutes before starting the ventilation
measure: HCO3
timeFrame: Every 20 minutes during ventilation
measure: HCO3
timeFrame: Up to 30 minutes post ventilation
measure: Serum Lactate
timeFrame: During the 30 minutes before starting the ventilation
measure: Serum Lactate
timeFrame: Every 20 minutes during ventilation
measure: Serum Lactate
timeFrame: Up to 30 minutes post ventilation
measure: Respiratory Rate
timeFrame: during ventilation
measure: Adverse Events
timeFrame: From date of study randomization until the end of treatment per each patient, up to 30 min post ventilation
Secondary outcomes:
measure: Room aerosol concentration
timeFrame: Before ventilation and during ventilation
measure: Use comfort
timeFrame: Up up 1 hour post ventilation
measure: Use comfort
timeFrame: Up up 1 hour post ventilation
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Ichilov
Study officials:
affiliation: Head of ICU
name: Nimrod Adi, Mr
role: PRINCIPAL_INVESTIGATOR
References: