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Completed

NCT Number: NCT04689542

Surgical Face Mask Effects 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Dyspnea Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Changes in respiratory rate

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

    Respiratory rate will be measured using two inductive plethysmography belts

  2. Changes in heart rate

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

    Heart rate will be measured using a pulse oximeter

  3. Changes in pulsed oxygen saturation (SpO2)

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

    SpO2 will be measured using a pulse oximeter

  4. Number of sit-to-stand repetition

    Time frame: 1 minute

    The number of repetitions will be manually counted

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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