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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346420
• Other study ID #: DTM-001
• Status: Completed
• Phase: N/A
• Start date: April 9, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID
• Hypoxemia
• Hypoxia

Intervention

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%.

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%.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	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
Secondary	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
Secondary	Changes in respiratory rate	Respiratory rate is measured during one minute by visual inspection.	At baseline and 30 minutes after wearing both systems