Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000277842p
Ethics application status
Submitted, not yet approved
Date submitted
26/12/2020
Date registered
12/03/2021
Date last updated
12/03/2021
Date data sharing statement initially provided
12/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of masks in hospital personnel and its association with subjective dyspnoea and oxygen saturation
Scientific title
Use of masks in hospital personnel and its association with subjective dyspnoea and oxygen saturation, a single centre randomised control blinded study
Secondary ID [1] 303079 0
None
Universal Trial Number (UTN)
U1111-1263-1488
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dyspnoea 320154 0
hypoxia 320155 0
anxiety 320156 0
Condition category
Condition code
Respiratory 318099 318099 0 0
Other respiratory disorders / diseases
Public Health 318100 318100 0 0
Health service research
Public Health 318319 318319 0 0
Other public health
Mental Health 318655 318655 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteer hospital staff shall be asked to wear 2 masks, for 4 hours each. Each phase shall be the same time of day, eg. morning between 0800 and 1200- and each of the three phases shall be on three consecutive work days. Wash out period is the rest of the day. These masks are a standard tri-layer surgical mask, and a fit tested N95 mask. The order in which participants shall wear the mask shall be randomised. Baseline questionnaires shall be completed by all participants, including demographic information (gender, height, weight, sex, age). A complete past medical and surgical history and list of current medications shall be obtained. Participants shall also fill in a number of baseline questionnaires relating to subjective dyspnoea, anxiety, depression and catastrophising. Baseline oxygen saturation and other vital parameters shall be obtained. The period of not wearing a mask and still having oxygen measurements is seperate to the wash out periods.
Strategies used to monitor adherence is direct observation at work by a study investigator, and 30 minutely measurements.
Intervention code [1] 319374 0
Treatment: Devices
Intervention code [2] 319375 0
Behaviour
Comparator / control treatment
Control group- crossover format of trial. All participants will have a 4 hour period of wearing no mask, ie. baseline control.
Control group
Active

Outcomes
Primary outcome [1] 326085 0
Subjective dyspnoea- as measured by a composite of the Borg scale and the MRC dyspnoea scale.
Timepoint [1] 326085 0
During mask wearing and also the 4 hour control period of no mask wearing. This shall be measured every 30 minutes for 4 hours during all three phases.
Secondary outcome [1] 390084 0
Oxygen saturation levels as assessed by pulse oximeter
Timepoint [1] 390084 0
Baseline, and also measured every 30 minutes during mask use, for 4 hours.
Secondary outcome [2] 390923 0
Activity, physical. Noted as direct general observations by the study team and text, for example- walking in ward rounds, or doing chest compressions for CPR.
Timepoint [2] 390923 0
Baseline, and every 30 minutes during mask use

Eligibility
Key inclusion criteria
Volunteer hospital staff at Flinders Medical Centre
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not fit tested for N95 mask use, declined to participate, allergy to masks, no availability of particular fit tested N95 mask

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations is not concealed.

The allocation shall be open, as participants will realise which mask they are wearing or if they are wearing no mask. It is the order of wearing masks or no mask that is randomised. All participants shall have all three phases: no mask, surgical mask, and N95 mask.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, centralised via www.sealedenvelope.com
1:1 basis
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
1/04/2022
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18263 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 18264 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 32326 0
5042 - Bedford Park
Recruitment postcode(s) [2] 32327 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 307484 0
Hospital
Name [1] 307484 0
Flinders medical centre
Country [1] 307484 0
Australia
Primary sponsor type
Hospital
Name
Flinders medical centre
Address
Flinders drive
Bedford park 5042
South Australia
Country
Australia
Secondary sponsor category [1] 308160 0
None
Name [1] 308160 0
None
Address [1] 308160 0
None
Country [1] 308160 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307558 0
Southern Area Local Health Network Human Research Ethics Committee
Ethics committee address [1] 307558 0
Flinders Dr, Bedford Park SA 5042
Ethics committee country [1] 307558 0
Australia
Date submitted for ethics approval [1] 307558 0
01/03/2021
Approval date [1] 307558 0
Ethics approval number [1] 307558 0

Summary
Brief summary
Volunteer hospital staff shall be asked to participate in three phases. The order of the phases shall be randomised. Each shall last for 4 hours. One phase is wearing a standard surgical trilayer mask. Another phase is wearing a fit tested N95 mask, And another is wearing no mask.
We shall ask you to complete some baseline questionnaires, a summary of your past medical history, a list of medications, a list of past operations, a psychological assessment tool assessing depression and anxiety, and how short of breath you are feeling. We will also measure your blood pressure, heart rate and oxygen level.
Every half an hour, a study investigator will come to you, and using a portable monitor shall measure your oxygen level and ask how short of breath you are feeling, using a scale from 0 to 10 and some simple questions relating dyspnoea to activity,.
We shall not show you what your oxygen levels are, a process we call "blinding".
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107670 0
Dr D-Yin Lin
Address 107670 0
Flinders Medical Centre
c/o Dept of Anaesthesia
Flinders Dr, Bedford Park SA 5042
Country 107670 0
Australia
Phone 107670 0
+61 434001819
Fax 107670 0
Email 107670 0
[email protected]
Contact person for public queries
Name 107671 0
Dr D-Yin Lin
Address 107671 0
Flinders Medical Centre
c/o Dept of Anaesthesia
Flinders Dr, Bedford Park SA 5042
Country 107671 0
Australia
Phone 107671 0
+61 434001819
Fax 107671 0
Email 107671 0
[email protected]
Contact person for scientific queries
Name 107672 0
Dr D-Yin Lin
Address 107672 0
Flinders Medical Centre
c/o Dept of Anaesthesia
Flinders Dr, Bedford Park SA 5042
Country 107672 0
Australia
Phone 107672 0
+61 434001819
Fax 107672 0
Email 107672 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
No plan to share


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10126Study protocol  [email protected]
10127Informed consent form  [email protected]
10128Ethical approval  [email protected]



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.