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

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

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

Study Overview

• Status: Completed
• Conditions: COVID; Hypoxemia
• Intervention / Treatment: Device: Double-Trunk Mask; Other: Standard interface

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: DTM-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No