Hypoxemia
Conditions
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.
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.
Interventions
DEVICEDouble-Trunk Mask
The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
DEVICENon-Rebreather mask
The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed