Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-flow nasal cannula | Active Comparator | The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM |
|
| Double-Trunk Mask | Experimental | The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). |
|
| Surgical Mask | Experimental | The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |