Covid19NCT04629989
Comparison of the Surgical Facemask With the Double-trunk Mask on Oxygenation in COVID-19
A study testing Standard Oxygen Delivery System, Double-Trunk Mask and Surgical Mask in people with Covid19 and Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Standard Oxygen Delivery System, Double-Trunk Mask and Surgical Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2020to 5 Mar 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
- COVID-19 positive
- SpO2 between 92 and 96% with low-flow oxygen therapy
- Oxygen output at baseline between 3 and 7 L/min.
Who cannot join
- Pulmonary disease with hypercapnia
- Confusion
- Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).
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 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 (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.
- Being tested
- Standard Oxygen Delivery System, Double-Trunk Mask, Surgical Mask
- Keywords
- Double-Trunk Mask, Surgical Mask
- Medical subject headings
- COVID-19, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Oxygen Delivery SystemOther
The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Double-Trunk MaskOther
The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Surgical MaskOther
The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Low-flow nasal cannula | Active comparator | The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM Receives: Other: Standard Oxygen Delivery System |
| Double-Trunk Mask | Experimental | The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). Receives: Other: Double-Trunk Mask |
| Surgical Mask | Experimental | The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). Receives: Other: Surgical Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PaO2
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
Measured: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Secondary outcomes (5)
Change in PaCO2
Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.
Measured: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Change in pH
Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.
Measured: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Change in respiratory rate
Respiratory rate is measured during one minute by visual inspection.
Measured: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Change in dyspnea
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Measured: At baseline and 60 minutes after wearing the randomized oxygen delivery system
Change in O2 output
The O2 output will be adjusted to recover the baseline SpO2 reading. The O2 output will be read from the position of the ball inside the flowmeter.
Measured: At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start13 Nov 2020
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629989
- Sponsor's protocol ID
- DTM-003
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
- ClinicalTrials.gov ID
- NCT04629989
- Acronym / sponsor ID
- DTM-003
- Keywords
- Double-Trunk Mask, Surgical Mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 16 Nov 2020 (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 two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).
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 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 (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-flow nasal cannula | Active comparator | Other: Standard Oxygen Delivery SystemThe standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM |
| Double-Trunk Mask | Experimental | Other: Double-Trunk MaskThe Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). |
| Surgical Mask | Experimental | Other: Surgical MaskThe Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 positive
- SpO2 between 92 and 96% with low-flow oxygen therapy
- Oxygen output at baseline between 3 and 7 L/min.
Key exclusion criteria (3 listed)
- Pulmonary disease with hypercapnia
- Confusion
- Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
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 |
|---|---|---|
| Standard Oxygen Delivery SystemThe standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour. | Other | Low-flow nasal cannula |
| Double-Trunk MaskThe Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour. | Other | Double-Trunk Mask |
| Surgical MaskThe Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour. | Other | Surgical Mask |
Primary outcome
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
5 secondary outcomes
Change in PaCO2
Time frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Change in pH
Time frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Change in respiratory rate
Time frame: At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Change in dyspnea
Time frame: At baseline and 60 minutes after wearing the randomized oxygen delivery system
Change in O2 output
Time frame: At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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 Standard Oxygen Delivery System, Double-Trunk Mask and Surgical Mask in people with Covid19 and Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in PaO2 (time frame: At baseline and 30 minutes after wearing the randomized oxygen delivery system). 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 9 Mar 2021.