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Completed

NCT Number: NCT04629989

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

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).

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hypoxemia Hypoxia Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Oxygen Delivery System

Other

The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Double-Trunk Mask

Other

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

Other

The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Primary outcomes

  1. 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 outcomes

  1. Change in PaCO2

    Time frame: 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.

  2. Change in pH

    Time frame: 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.

  3. Change in respiratory rate

    Time frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system

    Respiratory rate is measured during one minute by visual inspection.

  4. Change in dyspnea

    Time frame: At baseline and 60 minutes after wearing the randomized oxygen delivery system

    Dyspnea is rated with a visual analogic scale (0 to 100mm).

  5. Change in O2 output

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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