Respiratory FailureNCT05479773
Safety and Usability of the LUMENA Non-invasive Ventilation Mask
A study testing Standard NIV mask and Lumena NIV mask in people with Respiratory Failure, run by Inspir Labs Ltd. at 1 site in Israel.
Trial summary
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Standard NIV mask and Lumena NIV mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jun 2022to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Severe upper gastrointestinal bleeding.
- Chest trauma.
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center, Ichilov
Tel Aviv, 6423906
Yoel Angel, Mr, +972-544662007
Nimrod Adi, Mr
About this study
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
Read the 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.
- Conditions
- Respiratory Failure
- Being tested
- Standard NIV mask, Lumena NIV mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard NIV maskDevice
The hospital standered NIV mask
Lumena NIV maskDevice
aerosol-reducing mask
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Treatment order:
1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Standard NIV mask; Device: Lumena NIV mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPO2
Precentage of SPO2 before ventilation
Measured: During the 30 minutes before starting the ventilation
SPO2
Precentage of SPO2 during ventilation
Measured: Every 20 minutes during ventilation
SPO2
Precentage of SPO2 post ventilation
Measured: Up to 30 minutes post ventilation
pO2
mmHg of PO2 before ventilation
Measured: During the 30 minutes before starting the ventilation
pO2
mmHg of PO2 during ventilation and post ventilation
Measured: Every 20 minutes during ventilation
pO2
mmHg of PO2 post ventilation
Measured: Up to 30 minutes post ventilation
pCO2
pCO2 before ventilation measured in mmHg
Measured: During the 30 minutes before starting the ventilation
pCO2
pCO2 during ventilation measured in mmHg
Measured: Every 20 minutes during ventilation
pCO2
pCO2 post ventilation measured in mmHg
Measured: Up to 30 minutes post ventilation
pH
logarithmic units of pH before ventilation
Measured: During the 30 minutes before starting the ventilation
pH
logarithmic units of pH during ventilation
Measured: Every 20 minutes during ventilation
pH
logarithmic units of pH post ventilation
Measured: Up to 30 minutes post ventilation
HCO3
HCO3 before ventilation measured in mEq/L
Measured: During the 30 minutes before starting the ventilation
HCO3
HCO3 during ventilation measured in mEq/L
Measured: Every 20 minutes during ventilation
HCO3
HCO3 post ventilation measured in mEq/L
Measured: Up to 30 minutes post ventilation
Serum Lactate
Serum Lactate before ventilation measured in mmol/Lit
Measured: During the 30 minutes before starting the ventilation
Serum Lactate
Serum Lactate during ventilation measured in mmol/Lit
Measured: Every 20 minutes during ventilation
Serum Lactate
Serum Lactate post ventilation measured in mmol/Lit
Measured: Up to 30 minutes post ventilation
Respiratory Rate
Measuring of Respiratory Rate in breaths per minute, during ventilation
Measured: during ventilation
Adverse Events
Number of patients related Adverse Events as assessed by CTCAE v5.0
Measured: 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
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
Measured: 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.
Measured: 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.
Measured: Up up 1 hour post ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start23 Jun 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion22 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inspir Labs Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nimrod Adi, Mr, Principal investigator, Head of ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479773
- Sponsor's protocol ID
- 0818-21-TLV
- Status last verified
- Mar 2023
- First submitted
- 10 Jul 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of the LUMENA Non-invasive Ventilation Mask
- ClinicalTrials.gov ID
- NCT05479773
- Acronym / sponsor ID
- 0818-21-TLV
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Inspir Labs Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 22 Jun 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: Standard NIV mask, Device: Lumena NIV maskTreatment order: 1) Standard NIV mask ; 2) Lumena mask without suction ; 3) Lumena mask with suction. |
| Group B | Other | Device: Standard NIV mask, Device: Lumena NIV maskTreatment order: 1) Standard NIV mask ; 2) Lumena mask with suction ; 3) Lumena mask without suction. |
| Group C | Other | Device: Standard NIV mask, Device: Lumena NIV maskTreatment order: 1) Lumena mask without suction ; 2) Lumena mask with suction ; 3) Standard NIV mask. |
| Group D | Other | Device: Standard NIV mask, Device: Lumena NIV maskTreatment order: 1) Lumena mask with suction ; 2) Lumena mask without suction ; 3) Standard NIV mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard NIV maskThe hospital standered NIV mask | Device | Group A, Group B, Group C, Group D |
| Lumena NIV maskaerosol-reducing mask | Device | Group A, Group B, Group C, Group D |
Primary outcome
SPO2
Time frame: During the 30 minutes before starting the ventilation
Precentage of SPO2 before ventilation
SPO2
Time frame: Every 20 minutes during ventilation
Precentage of SPO2 during ventilation
SPO2
Time frame: Up to 30 minutes post ventilation
Precentage of SPO2 post ventilation
pO2
Time frame: During the 30 minutes before starting the ventilation
mmHg of PO2 before ventilation
pO2
Time frame: Every 20 minutes during ventilation
mmHg of PO2 during ventilation and post ventilation
pO2
Time frame: Up to 30 minutes post ventilation
mmHg of PO2 post ventilation
pCO2
Time frame: During the 30 minutes before starting the ventilation
pCO2 before ventilation measured in mmHg
pCO2
Time frame: Every 20 minutes during ventilation
pCO2 during ventilation measured in mmHg
pCO2
Time frame: Up to 30 minutes post ventilation
pCO2 post ventilation measured in mmHg
pH
Time frame: During the 30 minutes before starting the ventilation
logarithmic units of pH before ventilation
pH
Time frame: Every 20 minutes during ventilation
logarithmic units of pH during ventilation
pH
Time frame: Up to 30 minutes post ventilation
logarithmic units of pH post ventilation
HCO3
Time frame: During the 30 minutes before starting the ventilation
HCO3 before ventilation measured in mEq/L
HCO3
Time frame: Every 20 minutes during ventilation
HCO3 during ventilation measured in mEq/L
HCO3
Time frame: Up to 30 minutes post ventilation
HCO3 post ventilation measured in mEq/L
Serum Lactate
Time frame: During the 30 minutes before starting the ventilation
Serum Lactate before ventilation measured in mmol/Lit
Serum Lactate
Time frame: Every 20 minutes during ventilation
Serum Lactate during ventilation measured in mmol/Lit
Serum Lactate
Time frame: Up to 30 minutes post ventilation
Serum Lactate post ventilation measured in mmol/Lit
Respiratory Rate
Time frame: during ventilation
Measuring of Respiratory Rate in breaths per minute, during ventilation
Adverse Events
Time frame: 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
3 secondary outcomes
Room aerosol concentration
Time frame: Before ventilation and during ventilation
Use comfort
Time frame: Up up 1 hour post ventilation
Use comfort
Time frame: Up up 1 hour post ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimrod Adi, Mr principal investigator
Head of ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard NIV mask and Lumena NIV mask in people with Respiratory Failure, run by Inspir Labs Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadav Nahmias, Mr (+972-528512371, Nadav@inspirlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPO2 (time frame: During the 30 minutes before starting the ventilation). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.