None listed
Conditions
Brief summary
This assessment is designed to assess the Gallus NIV mask in a hospital environment, with regards to caregiver usability and the perceived participant comfort/tolerance. The Gallus mask aims to improve the safety and efficacy of the NIV therapy for patients. The features of the mask aim to improve the patient experience and reduce complications of NIV therapy. The assessment will be conducted at the Critical Care Department (Intensive Care Unit (ICU) and High Dependency Unit (HDU) of Waikato Hospital. All patients admitted to the Critical Care Department will be screened for eligibility for this assessment. Of the eligible patients, one hundred (100) will be recruited to be participants in the clinical assessment and will begin using the Gallus NIV mask at a time which the nursing staff caring for the participant see fit. At the end of each shift, the nursing staff caring for the participant will be asked to complete a Caregiver Feedback Form seeking information about how the Gallus NIV mask compares to the standard NIV mask used by the Hospital unit.
Interventions
The study will undertake clinical assessment of the Gallus noninvasive ventilation (NIV) mask in adult patients. Patients newly prescribed NIV will begin the therapy using the Gallus mask. Also, patients already receiving NIV via the hospital's standard mask may be changed over to the Gallus mask by the medical and nursing staff at a time they judge to be appropriate.
The Gallus mask is comprised of a silicon cushion which interfaces with the patient’s face and is supported by a plastic frame,
The study will undertake clinical assessment of the Gallus noninvasive ventilation (NIV) mask in adult patients. Patients newly prescribed NIV will begin the therapy using the Gallus mask. Also, patients already receiving NIV via the hospital's standard mask may be changed over to the Gallus mask by the medical and nursing staff at a time they judge to be appropriate. The Gallus mask is comprised of a silicon cushion which interfaces with the patient’s face and is supported by a plastic frame, in which there is an opening through which respiratory gas is delivered. A fabric headgear with adjustable straps attaches to the mask frame in four places with easy to use clips. This headgear over the head will be used to hold the mask in place on the patient’s face. The Gallus mask differs from the standard hospital mask in the shape of the mask, the shape of the cushion and the design of the headgear. The Gallus mask will be fitted on the patient by a nurse who will have received training on how to fit the mask. The nurse will open one of the lower clips, position the mask on the patient’s head and slide the head gear over the patient’s head. The fourth clip will be attached and the headgear straps adjusted to ensure that the mask fits securely but not too tightly onto the patients face. Study participants will use the Gallus mask for the duration of their time on NIV up to 14 days. The minimum duration on NIV is likely to be 1-2 hours. However, there is no minimum duration in the study protocol. The length of time that each patient has been using the Gallus mask on NIV is recorded in the caregiver feedback form. Comments on patient adherence to the therapy can me recorded in the comments section of the caregiver feedback form.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients admitted to the Critical Care Department of Waikato Hospital that require NIV will be screened for eligibility for the study. Study participants must be adult (18 years or older and weigh more than 30kg) and require NIV in the hospital setting.
Exclusion criteria
Patients that fall outside of the recommended sizing range for the Gallus mask will be excluded. Palliative care patients near the end of life may be omitted from the study if it is considered to be inappropriate to include them. Patients can be excluded at the caregiver's discretion, for example, patients with psychological issues or agitated patients.
Outcome results
None listed