None listed
Conditions
Brief summary
This clinical study aims to assess the feasibility of a novel NIV interface by evaluating patient comfort and tolerability of the interface relative to standard of care in the acute setting. It is hypothesized that the new interface can successfully treat acutely-ill patients requiring NIV therapy and its effect on patient comfort, tolerability, and ventilatory/physiological variables, including vital signs, are comparable to those of standard (commonly used) mask. .
Interventions
The intervention is a new nasal mask that can be used to deliver NIV (bi-level or continuous positive airway pressure (CPAP)) therapy for acutely-ill patients in intensive care unit (ICU) or high dependency unit (HDU). The new mask only sits inside the nostrils (that is, a nasal mask), and is designed to have improved flow dynamics.
Eligible participants who are already receiving NIV therapy through standard mask will be fitted with the new nasal mask by a treating clinician through which they
The intervention is a new nasal mask that can be used to deliver NIV (bi-level or continuous positive airway pressure (CPAP)) therapy for acutely-ill patients in intensive care unit (ICU) or high dependency unit (HDU). The new mask only sits inside the nostrils (that is, a nasal mask), and is designed to have improved flow dynamics. Eligible participants who are already receiving NIV therapy through standard mask will be fitted with the new nasal mask by a treating clinician through which they will receive the therapy for a period of 30 minutes. During this period, some basic information about participants, such as the level of oxygen saturation in their blood, will be recorded. Participants will also be asked to rate their level of comfort and degree of shortness of breath using appropriate validated rating scales.
Sponsors
Fisher & Paykel Healthcare Limited
Study design
Allocation
Non-randomised 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
Adult patients in the ICU and HDU already receiving bi-level or CPAP therapy. Fit cognitive state with the ability to provide informed consent.
Exclusion criteria
Patients receiving a nasogastric tube. Patients prescribed a CPAP pressure setting > 15 cm H2O. Patients prescribed a bilevel IPAP (inspiratory positive airway pressure) setting > 20 cmH2O. Patients prescribed a FiO2 (fraction of inspired oxygen) of >0.7 Non-spontaneously breathing Inability to provide consent Any other condition which, at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results.
Outcome results
None listed