Surgical Face Mask Effects in Patients With COVID-19

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Sit-To-Stand test

• Registration Number: NCT04689542
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Study Start: 2021-01-01
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Surgical Facemask	Sit-To-Stand test	The surgical facemask will be worn during the sit-to-stand test

Primary Outcome Measures

Name	Time	Method
Changes in dyspnea level	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium