Covid19, Hypoxemia
Conditions
Keywords
Double-Trunk Mask, Surgical Mask
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.
Interventions
The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
OTHERDouble-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.
OTHERSurgical 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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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). |
| 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. |
Countries
Belgium
Outcome results
None listed