None listed
Conditions
Brief summary
Non-invasive ventilation (NIV) is an effective treatment for a significant proportion of patients with acute respiratory failure, as well as chronic respiratory failure and sleep-disordered breathing. There are 2 main forms of NIV; continuous positive airway pressure (CPAP) and bi-level positive airway pressure (bi-level). Delivering NIV requires a ventilator device, with tubing and a mask that connects to the patients face using a soft cushion against the skin and straps around the back of the head. This study tests a new mask designed with soft plugs that occlude the nostrils, delivering pressurised air with a flow path that has been modified to better refresh the airways of carbon dioxide, the body's waste gas, Pre-clinical testing of the investigational mask has indicated it may improve washout of the upper airways compared to a standard nasal mask and thereby could reduce the work of breathing and improve comfort for people who require NIV therapy. Two variations of the new mask will be compared to a standard of care oronasal mask, to check how effectively it helps with breathing and how comfortable it feels when it is used.
Interventions
This study examines an investigational mask designed with soft plugs that occlude the inner nares, delivering gases with a flow path that has been modified to better refresh the anatomic dead space, with a low-profile adjustable harness system. Two variations of this novel nasal mask are compared to a standard of care oronasal mask in patients with chronic respiratory failure across continuous positive airway pressure (CPAP) and bi-level positive airway pressure at varying pressures. The study w
This study examines an investigational mask designed with soft plugs that occlude the inner nares, delivering gases with a flow path that has been modified to better refresh the anatomic dead space, with a low-profile adjustable harness system. Two variations of this novel nasal mask are compared to a standard of care oronasal mask in patients with chronic respiratory failure across continuous positive airway pressure (CPAP) and bi-level positive airway pressure at varying pressures. The study will be undertaken on a single day at a private research organisation and be supervised by doctors trained in non-invasive ventilatory (NIV) care. A doctor will provide 1:1 monitoring of ventilator settings, protocol adherence and patient adherence to therapy. Participants will trial the three masks in a randomised order. Each mask will tested across a 20-minute session of CPAP. There will be a 10-minute break between masks. The pressures during the 20-minute session of CPAP will start as 7cm H2O and be uptitrated by the doctor at 10-minutes to 12cm H2O for the remaining 10-minutes.
Sponsors
Fisher & Paykel Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A doctor’s diagnosis of a chronic respiratory and/or cardiovascular disease AND Oxygen saturation measured by pulse oximetry (SpO2) of less than or equal to 90% while breathing room air OR PtcCO2 greater than or equal to 45mmHg on transcutaneous monitor at baseline measurement
Exclusion criteria
• Age < 18 years • Unable to tolerate oxygen saturations on room air if on long term oxygen therapy • Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria • Suspected or proven infection with SARS-CoV-2 (COVID-19) • Risk of barotrauma, as assessed by the investigator • Nasal or facial conditions precluding use of NIV with nasal pillow or oronasal mask • Failure of mask fitting test • Intracranial trauma or trans-nasal neurosurgery (within 6 weeks) • Failure of PulmoVista 500 IET electrode belt fitting (low signal quality, poor skin integrity) • BMI >50 • Weight <50kg • Cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants • Self-reported current pregnancy • Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
Outcome results
None listed