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

NCT04346420 | Completed

• 1 other identifier: DTM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comfort with the interfaces

  30 minutes after wearing both systems

• Changes in PaO2

  At baseline and 30 minutes after wearing DTM

• Changes in PaCO2

  At baseline and 30 minutes after wearing DTM

• Changes in pH

  At baseline and 30 minutes after wearing DTM

• Changes in respiratory rate

  At baseline and 30 minutes after wearing both systems

Study Arms (2)

O2 DTM+

EXPERIMENTAL

The standard nasal cannula interface is accompanied with the DTM

Device: Double-Trunk Mask

O2 DTM-

ACTIVE COMPARATOR

The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM

Other: Standard interface

Interventions

Standard interface OTHER

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%.

O2 DTM-

Double-Trunk Mask DEVICE

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%.

O2 DTM+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19
• SpO2 between 92 and 96% with low-flow oxygen therapy (\< 15 L/min).

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: April 9, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

BE (1)