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
Qualifiers
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
Treatments tested in this trial
- Non-invasive ventilation mask with airway washout
- non-invasive ventilation