Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas

Covid19 Clinical Trial

Official title:

Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715854
• Other study ID #: lmcondorcet
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2021
• Source: Laboratory of Movement, Condorcet, Tournai, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19.

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 the 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 (1, 2) . However, no study has compared the effect on PaO2, of the addition of a classical aerosol mask above nasal canula.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Hypoxemia

Exclusion Criteria:

Hypercapnia

Confusion

Related Conditions & MeSH terms

• Covid19
• Emergencies
• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Mask
addition of the mask above the nasal cannulas

Locations

Country	Name	City	State
Belgium	Epicura	Hornu	Hainaut

Sponsors (1)

Lead Sponsor	Collaborator
Laboratory of Movement, Condorcet, Tournai, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PaO2 and PaCO2	Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ] Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system	30 minutes
Secondary	Respiratory frequency	Change in respiratory rate [ Time Frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ] Respiratory frequency is measured during one minute by visual inspection	1 minute