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

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

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).

Study Overview

• Status: Completed
• Conditions: Covid19; Hypoxemia
• Intervention / Treatment: Other: Standard Oxygen Delivery System; Other: Double-Trunk Mask; Other: Surgical Mask

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-flow nasal cannula; The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM	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.
Experimental: Double-Trunk Mask; The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).	Other: 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.
Experimental: Surgical Mask; The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Double-Trunk Mask; Surgical Mask
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Hypoxia
• Other Study ID Numbers: DTM-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No