Hypoxemic Respiratory FailureNCT04715854
Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas
A study testing Mask in people with Hypoxemic Respiratory Failure and Emergencies, run by Laboratory of Movement, Condorcet, Tournai, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure, Emergencies, Covid19
- What is being tested?
- Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypoxemia
Who cannot join
- Hypercapnia
- Confusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure
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.
Read the 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.
- Conditions
- Hypoxemic Respiratory Failure, Emergencies, Covid19
- Being tested
- Mask
- Keywords
- mask, oxygen
- Medical subject headings
- Respiratory Insufficiency, Emergencies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaskDevice
addition of the mask above the nasal cannulas
| Study group | Role | What they receive |
|---|---|---|
| Nasal canula (flexicare) | Active comparator | Patients will receive oxygen by classical nasal cannula Receives: 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) Receives: Device: Mask |
| Intersurgical aerosol mask | Active comparator | Patients will receive oxygen by classical nasal cannula associated with an aerosol mask Receives: Device: Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (1)
Respiratory frequency
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
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start19 Feb 2021
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratory of Movement, Condorcet, Tournai, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, frédéric Duprez, Laboratory of Movement, Condorcet, Tournai, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715854
- Sponsor's protocol ID
- lmcondorcet
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure
- ClinicalTrials.gov ID
- NCT04715854
- Acronym / sponsor ID
- lmcondorcet
- Conditions
- Hypoxemic Respiratory Failure, Emergencies, Covid19
- Keywords
- mask, oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Laboratory of Movement, Condorcet, Tournai, BelgiumUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nasal canula (flexicare) | Active comparator | Device: MaskPatients will receive oxygen by classical nasal cannula |
| Intersurgical aerosol mask with one hole closed by tape | Active comparator | Device: MaskPatients will receive oxygen by classical nasal cannula associated with an aerosol mask partially closed (one lateral hole of the face mask closed by tape) |
| Intersurgical aerosol mask | Active comparator | Device: MaskPatients will receive oxygen by classical nasal cannula associated with an aerosol mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypoxemia
Key exclusion criteria (2 listed)
- Hypercapnia
- Confusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maskaddition of the mask above the nasal cannulas | Device | Intersurgical aerosol mask, Intersurgical aerosol mask with one hole closed by tape, Nasal canula (flexicare) |
Primary outcome
Change in PaO2 and PaCO2
Time frame: 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
1 secondary outcome
Respiratory frequency
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask in people with Hypoxemic Respiratory Failure and Emergencies, run by Laboratory of Movement, Condorcet, Tournai, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaO2 and PaCO2 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.