Safety and Usability of the LUMENA Non-invasive Ventilation Mask

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Standard NIV mask; Device: Lumena NIV mask

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadav Nahmias, Mr; Phone Number: +972-528512371; Email: Nadav@inspirlabs.com
• Study Contact Backup: Name: Tal Shachar, Miss; Phone Number: +972-525308408; Email: Tal@inspirlabs.com

Study Locations

• Israel
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center, Ichilov
    • Contact: Yoel Angel, Mr; Phone Number: +972-544662007
    • Principal Investigator: Nimrod Adi, Mr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inspir Labs Ltd.
• Investigators: Principal Investigator: Nimrod Adi, Mr, Head of ICU

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 22, 2023

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 0818-21-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No