HypoxiaNCT03457363
Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia
A study testing DTM will be add above NC in people with Hypoxia, run by Laboratory of Movement, Condorcet, Tournai, Belgium at 1 site in Belgium.
Trial summary
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- DTM will be add above NC
- 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
- 20 Jun 2018to 20 Nov 2018
- 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
- Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 < 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel.
Who cannot join
- Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale < or = 12), acute confusional state.
- Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.
Read the detailed description
This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura).
The study consisted of two intervention periods separated by a washout period of 30 minutes.
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with hypoxia.
The protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. The study was performed in accordance with the Declaration of Helsinki.
- Conditions
- Hypoxia
- Being tested
- DTM will be add above NC
- Keywords
- oxygen, nasal cannula, double trunk mask, hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTM will be add above NCDevice
After oxygenation by classical nasal cannula, the DTM will be place above NC
| Study group | Role | What they receive |
|---|---|---|
| Double Trunk Mask | Experimental | DTM will be add above nasal cannula Receives: Device: DTM will be add above NC |
| Nasal Cannula Alone | Active comparator | Patients receive oxygen only thought nasal Cannula Receives: Device: DTM will be add above NC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
we will observe effect of adjunction of a DTM on PaO2
Measured: 30 minutes
Secondary outcomes (1)
PaCO2
we will observe the effect of the addition of the DTM on PaCO2
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start20 Jun 2018
- Primary completion20 Jul 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
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
- NCT03457363
- Sponsor's protocol ID
- Duprezbruyneel
- Status last verified
- Jul 2019
- First submitted
- 24 Feb 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oude Nijhuis JC, Haane DY, Koehler PJ. A review of the current and potential oxygen delivery systems and techniques utilized in cluster headache attacks. Cephalalgia. 2016 Sep;36(10):970-9. doi: 10.1177/0333102415616878. Epub 2015 Nov 12.
PubMed 26566938Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
PubMed 15871753Tiep BL, Nicotra B, Carter R, Belman MJ, Mittman C. Evaluation of a low-flow oxygen-conserving nasal cannula. Am Rev Respir Dis. 1984 Sep;130(3):500-2. doi: 10.1164/arrd.1984.130.3.500.
PubMed 6476597
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula
- ClinicalTrials.gov ID
- NCT03457363
- Acronym / sponsor ID
- Duprezbruyneel
- Conditions
- Hypoxia
- Keywords
- oxygen, nasal cannula, double trunk mask, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Laboratory of Movement, Condorcet, Tournai, BelgiumUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 7 Mar 2018 (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.
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.
Detailed description
This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura).
The study consisted of two intervention periods separated by a washout period of 30 minutes.
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with hypoxia.
The protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. The study was performed in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of level oxygenation between classical oxygenation with nasal canulae with or without adjunctive of a double trunk mask
| Arm | Type | Receives |
|---|---|---|
| Double Trunk Mask | Experimental | Device: DTM will be add above NCDTM will be add above nasal cannula |
| Nasal Cannula Alone | Active comparator | Device: DTM will be add above NCPatients receive oxygen only thought nasal Cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 < 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel.
Key exclusion criteria (2 listed)
- Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale < or = 12), acute confusional state.
- Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask.
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 |
|---|---|---|
| DTM will be add above NCAfter oxygenation by classical nasal cannula, the DTM will be place above NC | Device | Double Trunk Mask, Nasal Cannula Alone |
Primary outcome
Oxygenation
Time frame: 30 minutes
we will observe effect of adjunction of a DTM on PaO2
1 secondary outcome
PaCO2
Time frame: 30 minutes
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 23 Jul 2019.
- Background: PubMed 26566938Oude Nijhuis JC, Haane DY, Koehler PJ. A review of the current and potential oxygen delivery systems and techniques utilized in cluster headache attacks. Cephalalgia. 2016 Sep;36(10):970-9. doi: 10.1177/0333102415616878. Epub 2015 Nov 12.
- Background: PubMed 15871753Wettstein RB, Shelledy DC, Peters JI. Delivered oxygen concentrations using low-flow and high-flow nasal cannulas. Respir Care. 2005 May;50(5):604-9.
- Background: PubMed 6476597Tiep BL, Nicotra B, Carter R, Belman MJ, Mittman C. Evaluation of a low-flow oxygen-conserving nasal cannula. Am Rev Respir Dis. 1984 Sep;130(3):500-2. doi: 10.1164/arrd.1984.130.3.500.
- Individual participant dataSharing planned: No
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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 DTM will be add above NC in people with Hypoxia, 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: finished, as of the sponsor's last update on 23 Jul 2019. 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?
Oxygenation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457363, which also lists 3 linked publications.
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 23 Jul 2019.