Comparison of the Non-rebreather Mask With the Double-trunk Mask

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask

Conditions
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Hypoxemia

Intervention / Treatment
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* Device: Double-Trunk Mask
* Device: Non-Rebreather mask


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-Trunk Mask<br>The oxygen delivery system is the DTM | Device: Double-Trunk Mask<br>* The DTM (oxygen delivery system) is worn by the patient for 30 minutes.<br>|
| Active Comparator: Non-Rebreather Mask<br>The oxygen delivery system is the NRM | Device: Non-Rebreather mask<br>* The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 DTM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Comfort with the oxygen delivery 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 | 30 minutes after wearing both systems | 
| Dyspnea with the oxygen delivery systems | A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems | 30 minutes after wearing both systems |