HypoxemiaNCT04383821
Comparison of the Non-rebreather Mask With the Double-trunk Mask
A study testing Double-Trunk Mask and Non-Rebreather mask in people with Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
Trial summary
This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Double-Trunk Mask and Non-Rebreather mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesBelgium
- Study dates
- 15 May 2020to 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
- Acute hypoxemia not corrected with nasal cannula
Who cannot join
- Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
- Confusion
- Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
Epicura
Hornu
Centre Hospitalier Universitaire de Tivoli
La Louvière
About this study
Official title: Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask
This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of 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 the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.
- Conditions
- Hypoxemia
- Being tested
- Double-Trunk Mask, Non-Rebreather mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Trunk MaskDevice
The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
Non-Rebreather maskDevice
The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Double-Trunk Mask | Experimental | The oxygen delivery system is the DTM Receives: Device: Double-Trunk Mask |
| Non-Rebreather Mask | Active comparator | The oxygen delivery system is the NRM Receives: Device: Non-Rebreather 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 DTM
Secondary outcomes (5)
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
Comfort with the oxygen delivery systems
A Likert scale from -5 to +5 will be used to measure the subjective comfort of the patient while wearing both oxygen delivery systems
Measured: 30 minutes after wearing both systems
Dyspnea with the oxygen delivery systems
A Visual Analogic Scale 0 to 10 will be used to measure the dyspnea of the patient while wearing both oxygen delivery systems
Measured: 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 posted12 May 2020
- Study start15 May 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383821
- Sponsor's protocol ID
- DTM-002
- Status last verified
- Feb 2022
- First submitted
- 7 May 2020
- Last updated
- 8 Feb 2022
- 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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask
- ClinicalTrials.gov ID
- NCT04383821
- Acronym / sponsor ID
- DTM-002
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 12 May 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 the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of 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 the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-Trunk Mask | Experimental | Device: Double-Trunk MaskThe oxygen delivery system is the DTM |
| Non-Rebreather Mask | Active comparator | Device: Non-Rebreather maskThe oxygen delivery system is the NRM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute hypoxemia not corrected with nasal cannula
Key exclusion criteria (3 listed)
- Chronic obstructive pulmonary disease or other chronic respiratory 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 |
|---|---|---|
| Double-Trunk MaskThe DTM (oxygen delivery system) is worn by the patient for 30 minutes. | Device | Double-Trunk Mask |
| Non-Rebreather maskThe NRM (standard oxygen delivery system) is worn by the patient for 30 minutes. | Device | Non-Rebreather Mask |
Primary outcome
Changes in PaO2
Time frame: At baseline and 30 minutes after wearing DTM
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
5 secondary outcomes
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
Comfort with the oxygen delivery systems
Time frame: 30 minutes after wearing both systems
Dyspnea with the oxygen delivery systems
Time frame: 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 8 Feb 2022.
Related trials for Hypoxemia
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruitingObservational study
The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Hypoxemia
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-Trunk Mask and Non-Rebreather mask in people with Hypoxemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites 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 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 DTM). 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 8 Feb 2022.