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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-09

Study Completion Date

2020-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID Hypoxemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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O2 DTM+

The standard nasal cannula interface is accompanied with the DTM

Group Type EXPERIMENTAL

Double-Trunk Mask

Intervention Type 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-

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

Group Type ACTIVE_COMPARATOR

Standard interface

Intervention Type 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%.

Interventions

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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%.

Intervention Type OTHER

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%.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No