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

Not Applicable

Completed

• Conditions: COVID; Hypoxemia
• Interventions: Device: Double-Trunk Mask; Other: Standard interface

• Registration Number: NCT04346420
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2020-04-08
• Study Start: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
O2 DTM+	Double-Trunk Mask	The standard nasal cannula interface is accompanied with the DTM
O2 DTM-	Standard interface	The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Brussels Capital, Belgium