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

Not Applicable

• Conditions: Hypoxemic Respiratory Failure; Emergencies; Covid19
• Interventions: Device: Mask

• Registration Number: NCT04715854
• Lead Sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-16
• Study First Posted: 2021-01-20
• Study Start: 2021-02-19
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21
• Primary Completion: 2021-04-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Hypoxemia

Exclusion Criteria

Hypercapnia

Confusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intersurgical aerosol mask	Mask	Patients will receive oxygen by classical nasal cannula associated with an aerosol mask
Nasal canula (flexicare)	Mask	Patients will receive oxygen by classical nasal cannula
Intersurgical aerosol mask with one hole closed by tape	Mask	Patients will receive oxygen by classical nasal cannula associated with an aerosol mask partially closed (one lateral hole of the face mask closed by tape)

Primary Outcome Measures

Name	Time	Method
Change in PaO2 and PaCO2	30 minutes	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

Secondary Outcome Measures

Name	Time	Method
Respiratory frequency	1 minute	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

Trial Locations

Locations (1)

Epicura; 🇧🇪 Hornu, Hainaut, Belgium