Comparison of the Non-rebreather Mask With the Double-trunk Mask
Study Details
Study Description
Brief Summary
This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Double-Trunk Mask The oxygen delivery system is the DTM |
Device: Double-Trunk Mask
The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
|
| Active Comparator: Non-Rebreather Mask The oxygen delivery system is the NRM |
Device: Non-Rebreather mask
The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.
|
Outcome Measures
Primary Outcome Measures
- Changes in PaO2 [At baseline and 30 minutes after wearing DTM]
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Secondary Outcome Measures
- Changes in PaCO2 [At baseline and 30 minutes after wearing DTM]
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system
- Changes in pH [At baseline and 30 minutes after wearing DTM]
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
- Changes in respiratory rate [At baseline and 30 minutes after wearing both systems]
Respiratory rate is measured during one minute by visual inspection.
- Comfort with the oxygen delivery systems [30 minutes after wearing both systems]
A Likert scale from -5 to +5 will be used to measure the subjective comfort of the patient while wearing both oxygen delivery systems
- Dyspnea with the oxygen delivery systems [30 minutes after wearing both systems]
A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems
Eligibility Criteria
Criteria
Inclusion Criteria:
• Acute hypoxemia not corrected with nasal cannula
Exclusion Criteria:
-
Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
-
Confusion
-
Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | Belgium | 1200 |
| 2 | Epicura | Hornu | Belgium | ||
| 3 | Centre Hospitalier Universitaire de Tivoli | La Louvière | Belgium |
Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DTM-002