Surgical Face Mask Effects in Patients With COVID-19

Covid19 Clinical Trial

Official title:

Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689542
• Other study ID #: COSIT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 2, 2021

Study information

• Verified date: November 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Sit-To-Stand test
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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Before, immediately after and 2 minutes after the sit-to-stand test
Secondary	Changes in respiratory rate	Respiratory rate will be measured using two inductive plethysmography belts	Before, immediately after and 2 minutes after the sit-to-stand test
Secondary	Changes in heart rate	Heart rate will be measured using a pulse oximeter	Before, immediately after and 2 minutes after the sit-to-stand test
Secondary	Changes in pulsed oxygen saturation (SpO2)	SpO2 will be measured using a pulse oximeter	Before, immediately after and 2 minutes after the sit-to-stand test
Secondary	Number of sit-to-stand repetition	The number of repetitions will be manually counted	1 minute