Surgical Face Mask Effects in Patients With COVID-19

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT04689542
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 9.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Sit-To-Stand test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Apr 2, 2021
• Actual Study Completion Date: Apr 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Facemask The surgical facemask will be worn during the sit-to-stand test	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
No Intervention: Control No facemask will be worn during the sit-to-stand test

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. Number of sit-to-stand repetition [1 minute]

   The number of repetitions will be manually counted

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT04689542
• Other Study ID Numbers: COSIT
• First Posted: Dec 30, 2020
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain: Sit-To-Stand test; Surgical Facemask; Dyspnea
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Nov 8, 2021