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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04715854

Enrollment

Registered

2021-01-20

Start date

2021-02-19

Completion date

2021-07-01

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Emergencies, Hypoxemic Respiratory Failure

Keywords

mask, oxygen

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.

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.

Interventions

DEVICEMask

addition of the mask above the nasal cannulas

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Hypoxemia

Exclusion criteria

Hypercapnia Confusion

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026