Surgical Face Mask Effects in Patients With COVID-19

NCT04689542 | Completed

• 1 other identifier: COSIT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Sit-To-Stand test; Surgical Facemask; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in respiratory rate

  Before, immediately after and 2 minutes after the sit-to-stand test

• Changes in heart rate

  Before, immediately after and 2 minutes after the sit-to-stand test

• Changes in pulsed oxygen saturation (SpO2)

  Before, immediately after and 2 minutes after the sit-to-stand test

• Number of sit-to-stand repetition

  1 minute

Study Arms (2)

Surgical Facemask

EXPERIMENTAL

The surgical facemask will be worn during the sit-to-stand test

Other: Sit-To-Stand test

Control

NO INTERVENTION

No facemask will be worn during the sit-to-stand test

Interventions

Sit-To-Stand test OTHER

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

Surgical Facemask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized for COVID-19
• No need of supplemental oxygen during the procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

COVID-19; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2021
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

BE (1)