COVIDNCT04346420
Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
A study testing Standard interface and Double-Trunk Mask in people with COVID and Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Standard interface and Double-Trunk Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Apr 2020to 1 May 2020
- 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
- SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min).
Who cannot join
- Chronic obstructive pulmonary disease or other chronic respiratory disease
- Confusion
- Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
- Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.
Read the detailed description
The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.
Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.
- Being tested
- Standard interface, Double-Trunk Mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard interfaceOther
The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.
Double-Trunk MaskDevice
The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.
| Study group | Role | What they receive |
|---|---|---|
| O2 DTM+ | Experimental | The standard nasal cannula interface is accompanied with the DTM Receives: Device: Double-Trunk Mask |
| O2 DTM- | Active comparator | The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM Receives: Other: Standard interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in O2 output
The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.
Measured: At baseline and 30 minutes after wearing both systems
Secondary outcomes (5)
Comfort with the interfaces
A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM
Measured: 30 minutes after wearing both systems
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 DTM
Changes 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 DTM
Changes 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 DTM
Changes in respiratory rate
Respiratory rate is measured during one minute by visual inspection.
Measured: At baseline and 30 minutes after wearing both systems
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start9 Apr 2020
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04346420
- Sponsor's protocol ID
- DTM-001
- Status last verified
- Jun 2020
- First submitted
- 8 Apr 2020
- Last updated
- 9 Jun 2020
- 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 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04346420
- Acronym / sponsor ID
- DTM-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 15 Apr 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 investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.
Detailed description
The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.
Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O2 DTM+ | Experimental | Device: Double-Trunk MaskThe standard nasal cannula interface is accompanied with the DTM |
| O2 DTM- | Active comparator | Other: Standard interfaceThe standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COVID-19
- SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min).
Key exclusion criteria (4 listed)
- Chronic obstructive pulmonary disease or other chronic respiratory disease
- Confusion
- Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
- 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 interfaceThe standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%. | Other | O2 DTM- |
| Double-Trunk MaskThe standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%. | Device | O2 DTM+ |
Primary outcome
Change in O2 output
Time frame: At baseline and 30 minutes after wearing both systems
The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.
5 secondary outcomes
Comfort with the interfaces
Time frame: 30 minutes after wearing both systems
Changes in PaO2
Time frame: At baseline and 30 minutes after wearing DTM
Changes in PaCO2
Time frame: At baseline and 30 minutes after wearing DTM
Changes in pH
Time frame: At baseline and 30 minutes after wearing DTM
Changes in respiratory rate
Time frame: At baseline and 30 minutes after wearing both systems
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 Jun 2020.
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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 interface and Double-Trunk Mask in people with COVID 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 2 inclusion and 4 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 Jun 2020. 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?
Change in O2 output (time frame: At baseline and 30 minutes after wearing both systems). 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 Jun 2020.