Safety and Usability of the LUMENA Non-invasive Ventilation Mask

Not Applicable

Recruiting

• Conditions: Respiratory Failure
• Interventions: Device: Standard NIV mask; Device: Lumena NIV mask

• Registration Number: NCT05479773
• Lead Sponsor: Inspir Labs Ltd.

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.

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2022-07-10
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-04-01
• Study Completion: 2023-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Lumena NIV mask	Treatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction.
Group C	Standard NIV mask	Treatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask.
Group D	Standard NIV mask	Treatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask.
Group D	Lumena NIV mask	Treatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask.
Group B	Standard NIV mask	Treatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction.
Group A	Lumena NIV mask	Treatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction.
Group A	Standard NIV mask	Treatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction.
Group C	Lumena NIV mask	Treatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Use comfort	Up up 1 hour post ventilation	Staff member assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest.
Room aerosol concentration	Before ventilation and during ventilation	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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center, Ichilov; 🇮🇱 Tel Aviv, Israel