Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001120662
Ethics application status
Approved
Date submitted
4/10/2023
Date registered
27/10/2023
Date last updated
11/08/2024
Date data sharing statement initially provided
27/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of wearing a surgical mask or an N95 mask on patients with stable chronic hypercapnic respiratory failure currently using non-invasive ventilation? A randomised cross-over trial
Scientific title
What is the effect of wearing a surgical mask or an N95 mask on patients with stable chronic hypercapnic respiratory failure currently using non-invasive ventilation? A randomised cross-over trial
Secondary ID [1] 310805 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hypercapnic respiratory failure 331491 0
Condition category
Condition code
Respiratory 328225 328225 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, cross-over design study with 3 experimental arms i) no mask, ii) a surgical mask and iii) an N95 mask. The intervention will be delivered by specialist Respiratory Physiotherapists and participants will be done 1 by 1. Each experimental condition will last a maximum of 20 minutes or as long as tolerated by the participant. A washout period of at least 10 minutes between experimental conditions will also occur with the participant returning to baseline SpO2, RR and mBORG.
Prior to the study, demographics of all participants would be recorded including age, gender, primary diagnosis, diagnostic group, mean usage (hours) over the past 28 days and duration of NIV prescription (months). Spirometry in the seated position will be performed, measuring FEV1 and FVC. This will be performed using a mouth piece and nose clip; if there is inadequate lip seal a face mask will be used. Three measurements will be performed with the best effort recorded. Sudden nasal inspiratory pressure (SNIP) will also be measured with the contralateral nostril occluded over 5 trials with the best value used. The Multidimensional Profile (MDP) and mBORG will also be explained to the participant.
The participant will then be seated in a comfortable position, with finger oximetry (SpO2) (Radical-97, Masimo, CA) and transcutaneous carbon dioxide (TcCO2) (Sentec, Switzerland) monitoring commenced. An ear probe will be used for TcCO2 monitoring with the temperature probe set to 42 degrees Celsius. Heart rate (HR) will be recorded from the oximeter recording while respiratory rate will be obtained from respiratory bands placed around the participant’s upper chest and abdomen and recorded by a polygraphy (Alice 4 or Alice PDx systems, Philips, PA). All monitoring will be continuous throughout the study.
There will be concealed allocation for the randomisation of the test order of mask conditions (no mask, surgical mask (Primagard Procedure Mask with Earloop Blue PM4-306) or N95 mask (3M Aura) will occur, using block randomisation via REDCap (Research Electronic Data Capture). Participants will be fitted with a three-panel flat-fold type N95 mask (3M Aura 1870). A fit check will be performed with the participant asked to rapidly breathe in and then out. If air leaks are obvious after optimisation of nasal wire and head strap position, an alternative N95/P2 mask will be trialled and documented.
The protocol will commence with a 10-minute settling period sitting quietly. In the final minute the mBORG score will be recorded along with baseline SpO2, TcCO2, RR and HR. The first experimental condition will then commence with the participant instructed to sit quietly and not talk or sleep. They may however read. mBORG will be recorded at 5-minute intervals and at test cessation if unable to tolerate 20 min. During the final minute of the 20-minute experimental condition (or the longest period the participant can tolerate), the TDI will be administered. During the beginning of the 10-minute recovery period, the MDP will be completed. After a minimum 10-minute recovery period once SpO2, RR and TcCO2 have returned to baseline, the next allocated experimental condition will be undertaken, followed by another recovery period and then the final allocated experimental condition followed by final recovery period. The TDI and MDP will be administered at the end of each experimental condition as outlined above. At the conclusion of the experimental conditions the participant will be asked some simple questions about mask preference, factors contributing to tolerance and current mask practices. These questions are listed in the data collection form.
Intervention code [1] 327016 0
Treatment: Devices
Comparator / control treatment
The comparator will be the participant setting at rest with no mask insitu on ambient air. They will be instructed to rest quietly. They may read but should avoid talking or lauging. This is the same instructions in the surgical and N95 arms.
Control group
Active

Outcomes
Primary outcome [1] 336247 0
Oxygen saturation measured by a Pulse oximeter
Timepoint [1] 336247 0
baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement
Primary outcome [2] 336248 0
Transcutaneous carbon dioxide measured by a Sentec Device
Timepoint [2] 336248 0
baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement
Secondary outcome [1] 427524 0
Breathing discomfort using the A1 scale from the Multidimensional Dyspnea Profile
Timepoint [1] 427524 0
Baseline and the end of each experimental arm (20mins)
Secondary outcome [2] 427525 0
Heart Rate measured by pulse oximeter
Timepoint [2] 427525 0
baseline and at 5 minute intervals for during each 20mins experimental arm
Secondary outcome [3] 427526 0
Respiratory Rate measured by respiratory bands using Alice sleep system.
Timepoint [3] 427526 0
baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement
Secondary outcome [4] 427527 0
breathlessness as measured by Modified Borg Dyspnoea Scale
Timepoint [4] 427527 0
baseline and at 5 minute intervals for during each 20mins experimental arm, with the primary timepoint at 20 mins post commencement

Eligibility
Key inclusion criteria
1. Patients established on non-invasive ventilation (NIV) for the treatment of chronic hypercapnia for at least 28 days
2. Aged 18 years or over
3. Clinically stable (no change to respiratory medications in past 28 days) at the time of randomisation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Long-term oxygen therapy prescription with use during wakefulness.
2. NIV usage > 16 hrs / day
3. Normal lung function on spirometry
4. Unable to tolerate a surgical mask or N95 mask for more than 1 minute
5. Current inpatient
6. Current infection treated with antibiotics
7. Unable to provide consent due to significant mental health issues.
8. Patients who are unable to understand written or spoken English

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



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/11/2023
Actual
5/01/2024
Date of last participant enrolment
Anticipated
9/02/2024
Actual
30/07/2024
Date of last data collection
Anticipated
9/02/2024
Actual
30/07/2024
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25692 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41517 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314962 0
Hospital
Name [1] 314962 0
Royal Prince Alfred Hospital
Country [1] 314962 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 316960 0
None
Name [1] 316960 0
Address [1] 316960 0
Country [1] 316960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313829 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313829 0
Ethics committee country [1] 313829 0
Australia
Date submitted for ethics approval [1] 313829 0
25/09/2023
Approval date [1] 313829 0
15/11/2023
Ethics approval number [1] 313829 0
X23-0237 & 2023/ETH02129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129478 0
Mr Hayden Venville
Address 129478 0
RPA Hospital, Missenden Rd, Camperdown NSW 2050
Country 129478 0
Australia
Phone 129478 0
+61 0295158708
Fax 129478 0
Email 129478 0
[email protected]
Contact person for public queries
Name 129479 0
Hayden Venville
Address 129479 0
RPA Hospital, Missenden Rd, Camperdown NSW 2050
Country 129479 0
Australia
Phone 129479 0
+61 0295158708
Fax 129479 0
Email 129479 0
[email protected]
Contact person for scientific queries
Name 129480 0
Hayden Venville
Address 129480 0
RPA Hospital, Missenden Rd, Camperdown NSW 2050
Country 129480 0
Australia
Phone 129480 0
+61 0295158708
Fax 129480 0
Email 129480 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.