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

Not Applicable

Completed

• Conditions: Covid19; Hypoxemia
• Interventions: Other: Standard Oxygen Delivery System; Other: Double-Trunk Mask; Other: Surgical Mask

• Registration Number: NCT04629989
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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).

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 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.

Study Timeline

• Study Start: 2020-11-13
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Status Verified: 2021-03
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-flow nasal cannula	Standard Oxygen Delivery System	The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM
Double-Trunk Mask	Double-Trunk Mask	The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).
Surgical Mask	Surgical Mask	The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Primary Outcome Measures

Name	Time	Method
Changes in PaO2	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
Change in O2 output	At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system	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.
Change in pH	At baseline and 30 minutes after wearing the randomized oxygen delivery system	Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Change in PaCO2	At baseline and 30 minutes after wearing the randomized oxygen delivery system	Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.
Change in respiratory rate	At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system	Respiratory rate is measured during one minute by visual inspection.
Change in dyspnea	At baseline and 60 minutes after wearing the randomized oxygen delivery system	Dyspnea is rated with a visual analogic scale (0 to 100mm).

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium