Acute-on-chronic Respiratory FailureBoussignacNCT01788345
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
A study testing non- invasive ventilation in people with Acute-on-chronic Respiratory Failure, run by Vygon GmbH & Co. KG at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute-on-chronic Respiratory Failure
- What is being tested?
- non- invasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Dec 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 7,25 ≤ pH ≤ 7,35
- PaCO2 ≥ 45 mmHg
Who cannot join
- pH < 7,24
- incapable of collaboration
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.
- Conditions
- Acute-on-chronic Respiratory Failure
- Being tested
- non- invasive ventilation
- Keywords
- non-invasion ventilation, Boussignac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non- invasive ventilationOther
Also called Boussignac
non-invasive bi-level ventilation with IPAP and EPAP.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive ventilation | Experimental | Not described Receives: Other: non- invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinking pCO2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-on-chronic 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vygon GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Budweiser, PD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788345
- Sponsor's protocol ID
- 445-12
- Acronym
- Boussignac
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01788345
- Acronym / sponsor ID
- Boussignac / 445-12
- Conditions
- Acute-on-chronic Respiratory Failure
- Keywords
- non-invasion ventilation, Boussignac
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Vygon GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- 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 purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive ventilation | Experimental | Other: non- invasive ventilation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 7,25 ≤ pH ≤ 7,35
- PaCO2 ≥ 45 mmHg
Key exclusion criteria (2 listed)
- pH < 7,24
- incapable of collaboration
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 |
|---|---|---|
| non- invasive ventilationAlso: Boussignacnon-invasive bi-level ventilation with IPAP and EPAP. | Other | non-invasive ventilation |
Primary outcome
Sinking pCO2
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Boussignac, non-invasive ventilationLink provided by the sponsor.
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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.
Stephan Budweiser, PD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non- invasive ventilation in people with Acute-on-chronic Respiratory Failure, run by Vygon GmbH & Co. KG at 1 site in Germany.
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 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 11 Feb 2013. 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 Germany. 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?
Sinking pCO2 (time frame: 6 months). 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 11 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.