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Use of masks in hospital personnel and its association with subjective dyspnoea and oxygen saturation

Use of masks in hospital personnel and its association with subjective dyspnoea and oxygen saturation, a single centre randomised control blinded study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000277842
Enrollment
10
Registered
2021-03-12
Start date
2021-06-01
Completion date
2022-04-01
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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".

Interventions

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

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.

Sponsors

Flinders medical centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Volunteer hospital staff at Flinders Medical Centre

Exclusion criteria

Not fit tested for N95 mask use, declined to participate, allergy to masks, no availability of particular fit tested N95 mask

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026