Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas

NCT ID: NCT04715854

Last Updated: 2021-02-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-19

Study Completion Date

2021-07-01

Brief Summary

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This study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19.

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 the 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 (1, 2) . However, no study has compared the effect on PaO2, of the addition of a classical aerosol mask above nasal canula.

Conditions

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Hypoxemic Respiratory Failure Emergencies Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

One group will receive oxygen by classical nasal cannula. The second group will receive oxygen by aerosol mask associated with the nasal cannula. Afterward, the sequence will be inverted.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nasal canula (flexicare)

Patients will receive oxygen by classical nasal cannula

Group Type ACTIVE_COMPARATOR

Mask

Intervention Type DEVICE

addition of the mask above the nasal cannulas

Intersurgical aerosol mask with one hole closed by tape

Patients will receive oxygen by classical nasal cannula associated with an aerosol mask partially closed (one lateral hole of the face mask closed by tape)

Group Type ACTIVE_COMPARATOR

Mask

Intervention Type DEVICE

addition of the mask above the nasal cannulas

Intersurgical aerosol mask

Patients will receive oxygen by classical nasal cannula associated with an aerosol mask

Group Type ACTIVE_COMPARATOR

Mask

Intervention Type DEVICE

addition of the mask above the nasal cannulas

Interventions

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Mask

addition of the mask above the nasal cannulas

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Hypoxemia

Exclusion Criteria

Hypercapnia

Confusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratory of Movement, Condorcet, Tournai, Belgium

OTHER

Sponsor Role lead

Responsible Party

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frédéric Duprez

Deputy director, clinician, laboratory of movement Condorcet Belgium

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Epicura

Hornu, Hainaut, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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lmcondorcet

Identifier Type: -

Identifier Source: org_study_id

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