COVID, Hypoxemia
Conditions
Brief summary
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
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.
Interventions
DEVICEDouble-Trunk Mask
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%.
OTHERStandard interface
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%.
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in O2 output | At baseline and 30 minutes after wearing both systems | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort with the interfaces | 30 minutes after wearing both systems | 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 |
| 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 |
| 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. |
Countries
Belgium
Outcome results
None listed