Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
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|ClinicalTrials.gov Identifier: NCT04346420|
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID Hypoxemia||Other: Standard interface Device: Double-Trunk Mask||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19|
|Actual Study Start Date :||April 9, 2020|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
Experimental: O2 DTM+
The standard nasal cannula interface is accompanied with the DTM
Device: Double-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%.
Active Comparator: O2 DTM-
The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM
Other: Standard 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%.
- Change in O2 output [ Time Frame: 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.
- Comfort with the interfaces [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At baseline and 30 minutes after wearing both systems ]Respiratory rate is measured during one minute by visual inspection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346420
|Cliniques universitaires Saint-Luc|
|Brussels, Brussels Capital, Belgium, 1200|