Safety and Usability of the LUMENA Non-invasive Ventilation Mask

NCT05479773 | Unknown

• 1 other identifier: 0818-21-TLV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (3)

• Room aerosol concentration

  Before ventilation and during ventilation

• Use comfort

  Up up 1 hour post ventilation

• Use comfort

  Up up 1 hour post ventilation

Study Arms (4)

Group A

OTHER

Treatment order: 1\) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction.

Device: Standard NIV mask; Device: Lumena NIV mask

Group B

OTHER

Treatment order: 1\) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction.

Device: Standard NIV mask; Device: Lumena NIV mask

Group C

OTHER

Treatment order: 1\) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask.

Device: Standard NIV mask; Device: Lumena NIV mask

Group D

OTHER

Treatment order: 1\) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask.

Device: Standard NIV mask; Device: Lumena NIV mask

Interventions

Standard NIV mask DEVICE

The hospital standered NIV mask

Group A; Group B; Group C; Group D

Lumena NIV mask DEVICE

aerosol-reducing mask

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inspir Labs Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center, Ichilov

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Nimrod Adi, Mr

  Head of ICU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadav Nahmias, Mr

CONTACT

+972-528512371; Nadav@inspirlabs.com

Tal Shachar, Miss

CONTACT

+972-525308408; Tal@inspirlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 29, 2022
• Study Start: June 23, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 22, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)