Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Study Details
Study Description
Brief Summary
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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, 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, blood pressure (invasive and/or non-invasive), oxygen saturation, end-tidal capnography and temperature.
Electrocardiogram (ECG) diagrams before and after use. Arterial blood gas analysis for O2, CO2, pH and HCO3 as well as serum Lactate levels before, during (every 30 mins) 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 2.5ยต. Symptoms and signs during use of non-invasive ventilation (e.g. diaphoresis, anxiety).
Estimation of patient 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 and 5 being very comfortable, how would you rate the mask you are wearing? 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? 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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- SPO2 [During the 30 minutes before starting the ventilation]
Precentage of SPO2 before ventilation
- SPO2 [Every 20 minutes during ventilation]
Precentage of SPO2 during ventilation
- SPO2 [Up to 30 minutes post ventilation]
Precentage of SPO2 post ventilation
- pO2 [During the 30 minutes before starting the ventilation]
mmHg of PO2 before ventilation
- pO2 [Every 20 minutes during ventilation]
mmHg of PO2 during ventilation and post ventilation
- pO2 [Up to 30 minutes post ventilation]
mmHg of PO2 post ventilation
- pCO2 [During the 30 minutes before starting the ventilation]
pCO2 before ventilation measured in mmHg
- pCO2 [Every 20 minutes during ventilation]
pCO2 during ventilation measured in mmHg
- pCO2 [Up to 30 minutes post ventilation]
pCO2 post ventilation measured in mmHg
- pH [During the 30 minutes before starting the ventilation]
logarithmic units of pH before ventilation
- pH [Every 20 minutes during ventilation]
logarithmic units of pH during ventilation
- pH [Up to 30 minutes post ventilation]
logarithmic units of pH post ventilation
- HCO3 [During the 30 minutes before starting the ventilation]
HCO3 before ventilation measured in mEq/L
- HCO3 [Every 20 minutes during ventilation]
HCO3 during ventilation measured in mEq/L
- HCO3 [Up to 30 minutes post ventilation]
HCO3 post ventilation measured in mEq/L
- Serum Lactate [During the 30 minutes before starting the ventilation]
Serum Lactate before ventilation measured in mmol/Lit
- Serum Lactate [Every 20 minutes during ventilation]
Serum Lactate during ventilation measured in mmol/Lit
- 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
- 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
Secondary Outcome Measures
- 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
- Use comfort [Up up 1 hour post ventilation]
Patient assesment of use comfort of the worn mask, in units of 1 to 5 with 5 being the highest.
- 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.
Eligibility Criteria
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 Mechanical NIV, 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).
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.
-
Recent (< 6 months) myocardial infarction or stroke.
-
Severe upper gastrointestinal bleeding.
-
Chest trauma.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tel Aviv Sourasky Medical Center, Ichilov | Tel Aviv | Israel | 6423906 |
Sponsors and Collaborators
- Inspir Labs Ltd.
Investigators
- Principal Investigator: Nimrod Adi, Mr, Head of ICU
Study Documents (Full-Text)
More Information
Publications
None provided.- 0818-21-TLV