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

Sponsor

Laboratory of Movement, Condorcet, Tournai, Belgium (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04715854

Collaborator

(none)

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxemic Respiratory Failure Emergencies Covid19	Device: Mask	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure

Actual Study Start Date :

Feb 19, 2021

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nasal canula (flexicare) Patients will receive oxygen by classical nasal cannula	Device: Mask addition of the mask above the nasal cannulas
Active Comparator: 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)	Device: Mask addition of the mask above the nasal cannulas
Active Comparator: Intersurgical aerosol mask Patients will receive oxygen by classical nasal cannula associated with an aerosol mask	Device: Mask addition of the mask above the nasal cannulas

Arm

Intervention/Treatment

Active Comparator: Nasal canula (flexicare)

Patients will receive oxygen by classical nasal cannula

Device: Mask

addition of the mask above the nasal cannulas

Active Comparator: 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)

Device: Mask

addition of the mask above the nasal cannulas

Active Comparator: Intersurgical aerosol mask

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

Device: Mask

addition of the mask above the nasal cannulas

Outcome Measures

Primary Outcome Measures

Change in PaO2 and PaCO2 [30 minutes]
Changes in PaO2 [ Time Frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system ] Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

Secondary Outcome Measures

Respiratory frequency [1 minute]
Change in respiratory rate [ Time Frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system ] Respiratory frequency is measured during one minute by visual inspection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hypoxemia

Exclusion Criteria:

Hypercapnia

Confusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Epicura	Hornu	Hainaut	Belgium	7301

Sponsors and Collaborators

Laboratory of Movement, Condorcet, Tournai, Belgium

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

frédéric Duprez, Deputy director, clinician, laboratory of movement Condorcet Belgium, Laboratory of Movement, Condorcet, Tournai, Belgium

ClinicalTrials.gov Identifier:

NCT04715854

Other Study ID Numbers:

lmcondorcet

First Posted:

Jan 20, 2021

Last Update Posted:

Feb 21, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by frédéric Duprez, Deputy director, clinician, laboratory of movement Condorcet Belgium, Laboratory of Movement, Condorcet, Tournai, Belgium

mask, oxygen

Additional relevant MeSH terms:

Respiratory Insufficiency

Emergencies

Study Results

No Results Posted as of Feb 21, 2021