Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19

Conditions
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COVID, Hypoxemia

Intervention / Treatment
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* Other: Standard interface
* Device: Double-Trunk Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min). Exclusion Criteria: Chronic obstructive pulmonary disease or other chronic respiratory disease Confusion Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min 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: O2 DTM+<br>The standard nasal cannula interface is accompanied with the DTM | Device: Double-Trunk Mask<br>* 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%.<br>|
| Active Comparator: O2 DTM-<br>The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM | Other: Standard interface<br>* 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%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |