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Safety and Usability of the LUMENA Non-invasive Ventilation Mask

Primary Purpose

Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Standard NIV mask
Lumena NIV mask
Sponsored by
Inspir Labs Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Mechanical NIV, 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).

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. Recent (< 6 months) myocardial infarction or stroke.
  8. Severe upper gastrointestinal bleeding.
  9. Chest trauma.

Sites / Locations

  • Tel Aviv Sourasky Medical Center, IchilovRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Group A

Group B

Group C

Group D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

SPO2
Precentage of SPO2 before ventilation
SPO2
Precentage of SPO2 during ventilation
SPO2
Precentage of SPO2 post ventilation
pO2
mmHg of PO2 before ventilation
pO2
mmHg of PO2 during ventilation and post ventilation
pO2
mmHg of PO2 post ventilation
pCO2
pCO2 before ventilation measured in mmHg
pCO2
pCO2 during ventilation measured in mmHg
pCO2
pCO2 post ventilation measured in mmHg
pH
logarithmic units of pH before ventilation
pH
logarithmic units of pH during ventilation
pH
logarithmic units of pH post ventilation
HCO3
HCO3 before ventilation measured in mEq/L
HCO3
HCO3 during ventilation measured in mEq/L
HCO3
HCO3 post ventilation measured in mEq/L
Serum Lactate
Serum Lactate before ventilation measured in mmol/Lit
Serum Lactate
Serum Lactate during ventilation measured in mmol/Lit
Serum Lactate
Serum Lactate post ventilation measured in mmol/Lit
Respiratory Rate
Measuring of Respiratory Rate in breaths per minute, during ventilation
Adverse Events
Number of patients related Adverse Events as assessed by CTCAE v5.0

Secondary Outcome Measures

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
Use comfort
Patient assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest.
Use comfort
Staff member assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest.

Full Information

First Posted
July 10, 2022
Last Updated
March 12, 2023
Sponsor
Inspir Labs Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05479773
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspir Labs Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Treatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction.
Arm Title
Group B
Arm Type
Other
Arm Description
Treatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction.
Arm Title
Group C
Arm Type
Other
Arm Description
Treatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask.
Arm Title
Group D
Arm Type
Other
Arm Description
Treatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask.
Intervention Type
Device
Intervention Name(s)
Standard NIV mask
Intervention Description
The hospital standered NIV mask
Intervention Type
Device
Intervention Name(s)
Lumena NIV mask
Intervention Description
aerosol-reducing mask
Primary Outcome Measure Information:
Title
SPO2
Description
Precentage of SPO2 before ventilation
Time Frame
During the 30 minutes before starting the ventilation
Title
SPO2
Description
Precentage of SPO2 during ventilation
Time Frame
Every 20 minutes during ventilation
Title
SPO2
Description
Precentage of SPO2 post ventilation
Time Frame
Up to 30 minutes post ventilation
Title
pO2
Description
mmHg of PO2 before ventilation
Time Frame
During the 30 minutes before starting the ventilation
Title
pO2
Description
mmHg of PO2 during ventilation and post ventilation
Time Frame
Every 20 minutes during ventilation
Title
pO2
Description
mmHg of PO2 post ventilation
Time Frame
Up to 30 minutes post ventilation
Title
pCO2
Description
pCO2 before ventilation measured in mmHg
Time Frame
During the 30 minutes before starting the ventilation
Title
pCO2
Description
pCO2 during ventilation measured in mmHg
Time Frame
Every 20 minutes during ventilation
Title
pCO2
Description
pCO2 post ventilation measured in mmHg
Time Frame
Up to 30 minutes post ventilation
Title
pH
Description
logarithmic units of pH before ventilation
Time Frame
During the 30 minutes before starting the ventilation
Title
pH
Description
logarithmic units of pH during ventilation
Time Frame
Every 20 minutes during ventilation
Title
pH
Description
logarithmic units of pH post ventilation
Time Frame
Up to 30 minutes post ventilation
Title
HCO3
Description
HCO3 before ventilation measured in mEq/L
Time Frame
During the 30 minutes before starting the ventilation
Title
HCO3
Description
HCO3 during ventilation measured in mEq/L
Time Frame
Every 20 minutes during ventilation
Title
HCO3
Description
HCO3 post ventilation measured in mEq/L
Time Frame
Up to 30 minutes post ventilation
Title
Serum Lactate
Description
Serum Lactate before ventilation measured in mmol/Lit
Time Frame
During the 30 minutes before starting the ventilation
Title
Serum Lactate
Description
Serum Lactate during ventilation measured in mmol/Lit
Time Frame
Every 20 minutes during ventilation
Title
Serum Lactate
Description
Serum Lactate post ventilation measured in mmol/Lit
Time Frame
Up to 30 minutes post ventilation
Title
Respiratory Rate
Description
Measuring of Respiratory Rate in breaths per minute, during ventilation
Time Frame
during ventilation
Title
Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
Room aerosol concentration
Description
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
Title
Use comfort
Description
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
Title
Use comfort
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadav Nahmias, Mr
Phone
+972-528512371
Email
Nadav@inspirlabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Shachar, Miss
Phone
+972-525308408
Email
Tal@inspirlabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nimrod Adi, Mr
Organizational Affiliation
Head of ICU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center, Ichilov
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoel Angel, Mr
Phone
+972-544662007
First Name & Middle Initial & Last Name & Degree
Nimrod Adi, Mr

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Usability of the LUMENA Non-invasive Ventilation Mask

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