Covid19NCT04689542
Surgical Face Mask Effects in Patients With COVID-19
A study testing Sit-To-Stand test in people with Covid19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The use of personal protective equipment is mandatory for healthcare workers caring patient with COVID-19. To maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Sit-To-Stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized for COVID-19
- No need of supplemental oxygen during the procedure
Who cannot join
- Altered state of consciousness
- Respiratory co-morbidities
- Neurological or orthopedic co-morbidities susceptible to alter the reliability of the sit-to-stand test
- Having required high flow nasal cannula or non-invasive ventilation during the hospital stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19
The use of personal protective equipment is mandatory for healthcare workers caring patient with COVID-19. To maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. Routine clinical procedures include cardio-pulmonary and strengthening exercises. During these exercises, the wearing of a face mask may be difficult to tolerate by patients, especially since they experience breathing difficulties due to the illness. Therefore, this study aims to verify the effects of the surgical facemask on breathing difficulties and exercise performance during a 1-minute sit to stand test.
- Conditions
- Covid19
- Being tested
- Sit-To-Stand test
- Keywords
- Sit-To-Stand test, Surgical Facemask, Dyspnea
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit-To-Stand testOther
The 1-minute sit-to-stand test will be realized with or without a surgical facemask covering the face of the patient with COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Surgical Facemask | Experimental | The surgical facemask will be worn during the sit-to-stand test Receives: Other: Sit-To-Stand test |
| Control | No intervention | No facemask will be worn during the sit-to-stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dyspnea level
The Modified Borg dyspnea scale will be used to estimate dyspnea This scale range from 0 (no dyspnea) to 10 (maximal dyspnea)
Measured: Before, immediately after and 2 minutes after the sit-to-stand test
Secondary outcomes (4)
Changes in respiratory rate
Respiratory rate will be measured using two inductive plethysmography belts
Measured: Before, immediately after and 2 minutes after the sit-to-stand test
Changes in heart rate
Heart rate will be measured using a pulse oximeter
Measured: Before, immediately after and 2 minutes after the sit-to-stand test
Changes in pulsed oxygen saturation (SpO2)
SpO2 will be measured using a pulse oximeter
Measured: Before, immediately after and 2 minutes after the sit-to-stand test
Number of sit-to-stand repetition
The number of repetitions will be manually counted
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2021
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689542
- Sponsor's protocol ID
- COSIT
- Status last verified
- Nov 2021
- First submitted
- 29 Dec 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04689542
- Acronym / sponsor ID
- COSIT
- Conditions
- Covid19
- Keywords
- Sit-To-Stand test, Surgical Facemask, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of personal protective equipment is mandatory for healthcare workers caring patient with COVID-19. To maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. Routine clinical procedures include cardio-pulmonary and strengthening exercises. During these exercises, the wearing of a face mask may be difficult to tolerate by patients, especially since they experience breathing difficulties due to the illness. Therefore, this study aims to verify the effects of the surgical facemask on breathing difficulties and exercise performance during a 1-minute sit to stand test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Facemask | Experimental | Other: Sit-To-Stand testThe surgical facemask will be worn during the sit-to-stand test |
| Control | No intervention | –No facemask will be worn during the sit-to-stand test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized for COVID-19
- No need of supplemental oxygen during the procedure
Key exclusion criteria (4 listed)
- Altered state of consciousness
- Respiratory co-morbidities
- Neurological or orthopedic co-morbidities susceptible to alter the reliability of the sit-to-stand test
- Having required high flow nasal cannula or non-invasive ventilation during the hospital stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit-To-Stand testThe 1-minute sit-to-stand test will be realized with or without a surgical facemask covering the face of the patient with COVID-19 | Other | Surgical Facemask |
Primary outcome
Changes in dyspnea level
Time frame: Before, immediately after and 2 minutes after the sit-to-stand test
The Modified Borg dyspnea scale will be used to estimate dyspnea This scale range from 0 (no dyspnea) to 10 (maximal dyspnea)
4 secondary outcomes
Changes in respiratory rate
Time frame: Before, immediately after and 2 minutes after the sit-to-stand test
Changes in heart rate
Time frame: Before, immediately after and 2 minutes after the sit-to-stand test
Changes in pulsed oxygen saturation (SpO2)
Time frame: Before, immediately after and 2 minutes after the sit-to-stand test
Number of sit-to-stand repetition
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit-To-Stand test in people with Covid19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dyspnea level (time frame: Before, immediately after and 2 minutes after the sit-to-stand test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.