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This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.
The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.
Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O2 DTM+ | Experimental | The standard nasal cannula interface is accompanied with the DTM |
|
| O2 DTM- | Active Comparator | The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard interface | Other | The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in O2 output | The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters. | At baseline and 30 minutes after wearing both systems |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort with the interfaces | A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM | 30 minutes after wearing both systems |
| Changes in PaO2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Double-Trunk Mask | Device | The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%. |
|
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
| At baseline and 30 minutes after wearing DTM |
| Changes 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 DTM |
| Changes in pH | Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system. | At baseline and 30 minutes after wearing DTM |
| Changes in respiratory rate | Respiratory rate is measured during one minute by visual inspection. | At baseline and 30 minutes after wearing both systems |