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

NCT04715854 | Unknown

• 1 other identifier: lmcondorcet
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemic Respiratory Failure; Emergencies; Covid19

Keywords

mask, oxygen

Outcome Measures

Primary Outcomes (1)

• Change in PaO2 and PaCO2

  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

  30 minutes

Secondary Outcomes (1)

• Respiratory frequency

  1 minute

Study Arms (3)

Nasal canula (flexicare)

ACTIVE COMPARATOR

Patients will receive oxygen by classical nasal cannula

Device: Mask

Intersurgical aerosol mask with one hole closed by tape

ACTIVE COMPARATOR

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

Intersurgical aerosol mask

ACTIVE COMPARATOR

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

Device: Mask

Interventions

Mask DEVICE

addition of the mask above the nasal cannulas

Intersurgical aerosol mask; Intersurgical aerosol mask with one hole closed by tape; Nasal canula (flexicare)

Eligibility Criteria

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

You may qualify if:

• Hypoxemia

You may not qualify if:

• Hypercapnia
• Confusion

Sponsors & Collaborators

• Laboratory of Movement, Condorcet, Tournai, Belgium: lead

Study Sites (1)

Epicura

Hornu, Hainaut, 7301, Belgium

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Emergencies; COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, clinician, laboratory of movement Condorcet Belgium

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 20, 2021
• Study Start: February 19, 2021
• Primary Completion: April 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-01

Locations

BE (1)