NIV With Airway Washout for Dual Limb Ventilation: Improvement in Minute Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFisher and Paykel Healthcare
About this trial
This is a prospective, non-randomized, non-blinded, crossover feasibility investigation to assess the safety, usability, and efficacy of the investigational mask in the hospital environment. Eligible patients that are stable in NIV and able to give informed consent will be approached and if they consent the patient will be included in the study. If potential participants decline, normal hospital care will be continued. The enrolled participant will receive NIV on the commercially available Visairo mask for one hour during which their ventilatory parameters will be logged. Then the participant will be switched to the investigational mask for another hour. The ventilator data will be collected for these two hours. At the end of the intervention the participant will be reverted to their original mask. The medical staff will be asked to fill out the case report form pertaining to the function and usability of the investigational mask compared to the conventional mask.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults admitted to the ICU prescribed NIV and stable
Able to receive therapy on a sub-nasal (under-the-nose) mask
Are 18 years old or older
Disqualifiers
Contraindicated for NIV
NIV is likely to fail and/or intubation be required, at the medical staff's discretion
Bilevel pressure of ≥ 30 cmH2O required
Do not fit the investigational mask or the standard mask
Trial design
Design model
Crossover
Treatments tested in this trial
Non-invasive ventilation mask with airway washout
Other interventionNon-invasive ventilation mask with airway washout for dual limb ventilators
non-invasive ventilation
Other interventionstandard state of the art non-invasive ventilation
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: VisairoActive comparator 1 intervention
Group B: OptiNIV DualExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
minute ventilation
To establish that the performance of the investigational mask is on par or better than a conventional NIV. Comparing the Visairo and the investigational masks for a reduction in minute ventilation over the 1 hour study period. We anticipate a reduction in minute ventilation that is 2L/min less than in the comparator mask. This will be established with a paired T test over the first 5 and last 5 min of data extracted from the ventilator.
Time frame
The first 5 minutes on each mask will be compared to the last 5 minutes on the same mask and the differences compared by paired T-test.Secondary outcomes
1
Ventilator data (pressure)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Pressure data will be compared via paired T-test between arms.
Time frame
Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.2
Ventilator data (flow)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Flow data will be compared via paired T-test between arms.
Time frame
Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.3
user feedback
To establish that the safety, usability and performance of the investigational mask is on par with a conventional NIV, according to the attending nurse/healthcare provider. The attending nurse/healthcare provider will complete a questionnaire, comparing the Visairo and the OptiNIV dual masks. Whether the masks performed similarly, ease of therapy establishment, if any asynchrony was noticed, if in their opinion the participants were equally comfortable in both masks. This is qualitative data, each of the 5 questions will be given a score from 1-5 for a maximum of 25. a Score of 8-17 being neutral below will favor the conventional mask above will favor the investigational mask.
Time frame
once both arms are completed, right after the 2 hours on NIV4
Ventilator data (leak)
Data will be downloaded from the ventilator after the trial is concluded. This will include pressure flow and leak data as well as alarms and settings. This data will be compared between arms to see if the ventilators behave statistically different between arms and if so on what parameters. Leak data will be compared via paired T-test between arms.
Time frame
Ventilator data can be logged in 5 min intervals the study data ie 1h on visairo and 1h on optiniv dual will be exported to USB after the participant has concluded both arms.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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