COPDNCT01987661
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
A study testing BIPAP ST and Airtrap in people with COPD and Hypercapnic Respiratory Failure, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, Hypercapnic Respiratory Failure
- What is being tested?
- BIPAP ST and Airtrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to 1 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable respiratory situation
- Clinically required NIV
- Capable of giving consent
Who cannot join
- Invasive ventilation
- Any other severe physical disease that requires immediate medical assistance
- Acute hypercapnic decompensation with pH <7.30 in routine BGA
- Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
- Participation in a clinical trial within the last 4 weeks
- Pregnancy or nursing period
- Drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.
Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Being tested
- BIPAP ST, Airtrap
- Keywords
- COPD, NIV, Airtrapping, Ventimotion2
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAP STDevice
Also called Ventimotion 2
non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
AirtrapDevice
Also called Ventimotion 2, Weinmann
Addional to the individally titrated BiPAP ventilation parameters the function "AirTrap Control" is added.
AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time.
| Study group | Role | What they receive |
|---|---|---|
| bilevel ventilation BIPAP ST | Active comparator | one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary. Receives: Device: BIPAP ST |
| BIPAP ST plus Airtrap | Experimental | one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen. Receives: Device: BIPAP ST; Device: Airtrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
breathing frequency
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
Measured: 2 nights
Secondary outcomes (1)
mean pCO2 level
mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)
Measured: 2 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Responsible party
- Principal investigator, Georg Nilius, Institut für Pneumologie Hagen Ambrock eV
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Hagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987661
- Sponsor's protocol ID
- Airtrap2013
- Status last verified
- Feb 2019
- First submitted
- 13 Nov 2013
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten
- ClinicalTrials.gov ID
- NCT01987661
- Acronym / sponsor ID
- Airtrap2013
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Keywords
- COPD, NIV, Airtrapping, Ventimotion2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Study start
- Oct 2013
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 19 Nov 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.
15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.
Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilevel ventilation BIPAP ST | Active comparator | Device: BIPAP STone night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary. |
| BIPAP ST plus Airtrap | Experimental | Device: BIPAP ST, Device: Airtrapone night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable respiratory situation
- Clinically required NIV
- Capable of giving consent
Key exclusion criteria (7 listed)
- Invasive ventilation
- Any other severe physical disease that requires immediate medical assistance
- Acute hypercapnic decompensation with pH <7.30 in routine BGA
- Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
- Participation in a clinical trial within the last 4 weeks
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 |
|---|---|---|
| BIPAP STAlso: Ventimotion 2non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure. | Device | BIPAP ST plus Airtrap, bilevel ventilation BIPAP ST |
| AirtrapAlso: Ventimotion 2, WeinmannAddional to the individally titrated BiPAP ventilation parameters the function "AirTrap Control" is added. AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time. | Device | BIPAP ST plus Airtrap |
Primary outcome
breathing frequency
Time frame: 2 nights
breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night
1 secondary outcome
mean pCO2 level
Time frame: 2 nights
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 11 Feb 2019.
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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.
Georg Nilius, MD principal investigator
Helios Klinik Hagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAP ST and Airtrap in people with COPD and Hypercapnic Respiratory Failure, run by Institut für Pneumologie Hagen Ambrock eV 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 3 inclusion and 7 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 11 Feb 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 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?
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?
breathing frequency (time frame: 2 nights). 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 2019.