Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19

NCT ID: NCT04629989

Last Updated: 2021-03-09

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2021-03-05

Brief Summary

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This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).

Detailed Description

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Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.

Conditions

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Covid19 Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-flow nasal cannula

The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM

Group Type ACTIVE_COMPARATOR

Standard Oxygen Delivery System

Intervention Type OTHER

The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Double-Trunk Mask

The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Group Type EXPERIMENTAL

Double-Trunk Mask

Intervention Type OTHER

The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Surgical Mask

The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).

Group Type EXPERIMENTAL

Surgical Mask

Intervention Type OTHER

The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Interventions

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Standard Oxygen Delivery System

The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Intervention Type OTHER

Double-Trunk Mask

The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Intervention Type OTHER

Surgical Mask

The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* COVID-19 positive
* SpO2 between 92 and 96% with low-flow oxygen therapy
* Oxygen output at baseline between 3 and 7 L/min.

Exclusion Criteria

* Pulmonary disease with hypercapnia
* Confusion
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Poncin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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DTM-003

Identifier Type: -

Identifier Source: org_study_id

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