Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19

Covid19 Clinical Trial

Official title:

The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629989
• Other study ID #: DTM-003
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: March 5, 2021

Study information

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

Clinical Trial Summary

This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).

Description:

Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COVID-19 positive

• SpO2 between 92 and 96% with low-flow oxygen therapy

• Oxygen output at baseline between 3 and 7 L/min.

Exclusion Criteria:

• Pulmonary disease with hypercapnia

• Confusion

• Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Related Conditions & MeSH terms

• Covid19
• Hypoxemia
• Hypoxia

Intervention

Other:
• Standard Oxygen Delivery System
The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
• Double-Trunk Mask
The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
• Surgical Mask
The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

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 PaO2	Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system	At baseline and 30 minutes after wearing the randomized oxygen delivery system
Secondary	Change in PaCO2	Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.	At baseline and 30 minutes after wearing the randomized oxygen delivery system
Secondary	Change in pH	Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.	At baseline and 30 minutes after wearing the randomized oxygen delivery system
Secondary	Change in respiratory rate	Respiratory rate is measured during one minute by visual inspection.	At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Secondary	Change in dyspnea	Dyspnea is rated with a visual analogic scale (0 to 100mm).	At baseline and 60 minutes after wearing the randomized oxygen delivery system
Secondary	Change in O2 output	The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.	At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system