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Trial registered on ANZCTR


Registration number
ACTRN12618001780246
Ethics application status
Approved
Date submitted
26/10/2018
Date registered
30/10/2018
Date last updated
27/01/2022
Date data sharing statement initially provided
30/10/2018
Date results information initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical assessment of Gallus noninvasive ventilation (NIV) mask on patients in intensive care prescribed NIV.
Scientific title
Clinical assessment of Gallus noninvasive ventilation (NIV) mask on patients in intensive care prescribed NIV.
Secondary ID [1] 296407 0
None
Universal Trial Number (UTN)
U1111-1218-6794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-invasive ventilation 310162 0
Condition category
Condition code
Respiratory 308912 308912 0 0
Chronic obstructive pulmonary disease
Respiratory 308913 308913 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312759 0
Treatment: Devices
Comparator / control treatment
No control group. The caregiver's subjective opinion of the Gallus mask compared to the standard care NIV mask of the unit will be assessed. The two masks will not be directly compared.
Control group
Active

Outcomes
Primary outcome [1] 307903 0
Caregiver usability will be assessed using a carer feedback form where the carer is asked to rate the patient care experience and delivery of NIV therapy compared to the standard hospital mask.
Timepoint [1] 307903 0
At the end of each 8 hour or 12 hour nursing shift for the duration of time that the patient is on NIV therapy using the Gallus mask, for up to 14 days.
Secondary outcome [1] 353279 0
Caregiver perceived participant comfort is recorded by the nurse completing a caregiver feedback form, where they are asked to subjectively compare comfort compared to the standard mask used in the unit. This occurs at the end of each nursing shift, which can be 8 hours or 12 hours for up to 14 days.
Timepoint [1] 353279 0
At the end of each nursing shift for the duration of time that the patient is on NIV therapy using the Gallus mask. This occurs at the end of each nursing shift, which can be 8 hours or 12 hours for up to 14 days.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2018
Actual
6/11/2018
Date of last participant enrolment
Anticipated
26/04/2019
Actual
27/08/2019
Date of last data collection
Anticipated
31/07/2020
Actual
29/08/2019
Sample size
Target
100
Accrual to date
Final
67
Recruitment outside Australia
Country [1] 20954 0
New Zealand
State/province [1] 20954 0

Funding & Sponsors
Funding source category [1] 301016 0
Commercial sector/Industry
Name [1] 301016 0
Fisher and Paykel Healthcare
Country [1] 301016 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place,
East Tamaki,
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 300625 0
None
Name [1] 300625 0
None
Address [1] 300625 0
None
Country [1] 300625 0
Other collaborator category [1] 280409 0
Hospital
Name [1] 280409 0
Department of Critical Care
Address [1] 280409 0
Department of Critical Care,
Waikato Hospital
Pembroke Street,
Hamilton 3204
Country [1] 280409 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301771 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 301771 0
Ministry of Health,
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 301771 0
New Zealand
Date submitted for ethics approval [1] 301771 0
24/05/2018
Approval date [1] 301771 0
15/10/2018
Ethics approval number [1] 301771 0
18/NTA/136

Summary
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.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88046 0
Dr Robert Martynoga
Address 88046 0
Department of Critical Care,
Waikato Hospital
Pembroke Street,
Hamilton 3204
Country 88046 0
New Zealand
Phone 88046 0
+64 21 834 557
Fax 88046 0
Email 88046 0
[email protected]
Contact person for public queries
Name 88047 0
Robert Martynoga
Address 88047 0
Department of Critical Care,
Waikato Hospital
Pembroke Street,
Hamilton 3204
Country 88047 0
New Zealand
Phone 88047 0
+64 21 834 557
Fax 88047 0
Email 88047 0
[email protected]
Contact person for scientific queries
Name 88048 0
Robert Martynoga
Address 88048 0
Department of Critical Care,
Waikato Hospital
Pembroke Street,
Hamilton 3204
Country 88048 0
New Zealand
Phone 88048 0
+64 21 834 557
Fax 88048 0
Email 88048 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The study demonstrated that the medical device was... [More Details]

Documents added automatically
No additional documents have been identified.