Back to resultsSurgical Face Mask Effects in Patients With COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sit-To-Stand test
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring Sit-To-Stand test, Surgical Facemask, Dyspnea
Eligibility Criteria
Inclusion Criteria:
- Hospitalized for COVID-19
- No need of supplemental oxygen during the procedure
Exclusion Criteria:
- 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
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surgical Facemask
Control
Arm Description
The surgical facemask will be worn during the sit-to-stand test
No facemask will be worn during the sit-to-stand test
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes in respiratory rate
Respiratory rate will be measured using two inductive plethysmography belts
Changes in heart rate
Heart rate will be measured using a pulse oximeter
Changes in pulsed oxygen saturation (SpO2)
SpO2 will be measured using a pulse oximeter
Number of sit-to-stand repetition
The number of repetitions will be manually counted
Full Information
NCT ID
NCT04689542
First Posted
December 29, 2020
Last Updated
November 5, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04689542
Brief Title
Surgical Face Mask Effects in Patients With COVID-19
Official Title
Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
April 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Sit-To-Stand test, Surgical Facemask, Dyspnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical Facemask
Arm Type
Experimental
Arm Description
The surgical facemask will be worn during the sit-to-stand test
Arm Title
Control
Arm Type
No Intervention
Arm Description
No facemask will be worn during the sit-to-stand test
Intervention Type
Other
Intervention Name(s)
Sit-To-Stand test
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in dyspnea level
Description
The Modified Borg dyspnea scale will be used to estimate dyspnea This scale range from 0 (no dyspnea) to 10 (maximal dyspnea)
Time Frame
Before, immediately after and 2 minutes after the sit-to-stand test
Secondary Outcome Measure Information:
Title
Changes in respiratory rate
Description
Respiratory rate will be measured using two inductive plethysmography belts
Time Frame
Before, immediately after and 2 minutes after the sit-to-stand test
Title
Changes in heart rate
Description
Heart rate will be measured using a pulse oximeter
Time Frame
Before, immediately after and 2 minutes after the sit-to-stand test
Title
Changes in pulsed oxygen saturation (SpO2)
Description
SpO2 will be measured using a pulse oximeter
Time Frame
Before, immediately after and 2 minutes after the sit-to-stand test
Title
Number of sit-to-stand repetition
Description
The number of repetitions will be manually counted
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized for COVID-19
No need of supplemental oxygen during the procedure
Exclusion Criteria:
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
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Surgical Face Mask Effects in Patients With COVID-19
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