COPDNCT01986413
Intelligent Volume Assured Pressure Support to Improve Sleep Quality and Respiratory Events in Patients With Non Invasive Ventilation
A study testing volume assured pressure support IVAPS and NIV in people with COPD and Chronic Hypercapnic Respiratory Failure, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD, Chronic Hypercapnic Respiratory Failure
- What is being tested?
- volume assured pressure support IVAPS and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jun 2014
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable respiratory insufficiency
- Hypercapnia >50 mmHG
- Clinically required NIV
- Capable of giving consent
Who cannot join
- Existing ventilatory support
- 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 Gesichertem Atemminutenvolumen Auf Schlafqualität Und Häufigkeit Respiratorischer Ereignisse Bei Patienten Mit Nicht Invasiver Beatmung (NIV)
Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation.
20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.
Read the detailed description
Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years. Especially continuous positive airway pressure (CPAP) is the established Gold Standard in obstructive sleep apnea (OSA) treatment.
NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic respiratory failure, especially in exacerbated COPD.
Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP) but also of inspiration pressure support. Only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. The pressure changes need to be defined by the physician, as well as the breathing frequency.
Ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled).
Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask.
There is a lack of systematic studies addressing the effects of different ventilator settings on sleep and life quality, as well as studies about the necessary monitoring extent during the NIV initiation.
- Conditions
- COPD, Chronic Hypercapnic Respiratory Failure
- Being tested
- pressure controlled ventilation BIPAP ST, volume assured pressure support IVAPS, NIV
- Keywords
- COPD, chronic hypercapnic respiratory failure, NIV, respiratory events, IVAPS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure controlled ventilation BIPAP STDevice
Also called Stellar™ 150, ResMed
spontaneous timed pressure controled bilevel ventilation
volume assured pressure support IVAPSDevice
Also called Stellar™ 150 with iVAPS
intelligent volume assured Pressure Support
NIVDevice
Also called Stellar™ 150, ResMed
Patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP ST) and one with the advanced mode of intelligent volume assured pressure support (IVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement.
| Study group | Role | What they receive |
|---|---|---|
| BIPAP ST | Active comparator | one night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters. Receives: Device: pressure controlled ventilation BIPAP ST; Device: NIV |
| IVAPS | Experimental | one night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels. Receives: Device: volume assured pressure support IVAPS; Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of respiratory events during non invasive ventilation
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea
Measured: 2 nights
Secondary outcomes (1)
Sleep efficiency
Relation between "time in bed" and "total sleep time" measured by a polysomnography under non invasive ventilation.
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 posted18 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionJun 2014
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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Georg Nilius, Helios Klinik Ambrock
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Hagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986413
- Sponsor's protocol ID
- IVAPSleep 2013
- Status last verified
- Mar 2015
- First submitted
- 11 Nov 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German: Einfluss Von Gesichertem Atemminutenvolumen Auf Schlafqualität Und Häufigkeit Respiratorischer Ereignisse Bei Patienten Mit Nicht Invasiver Beatmung (NIV)
- ClinicalTrials.gov ID
- NCT01986413
- Acronym / sponsor ID
- IVAPSleep 2013
- Conditions
- COPD, Chronic Hypercapnic Respiratory Failure
- Keywords
- COPD, chronic hypercapnic respiratory failure, NIV, respiratory events, IVAPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- ResMed
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 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.
Aim of this prospective randomized trial is to compare non invasive ventilation (NIV) with pressure control (BiPAP-ST) to volume assured pressure support (iVAPS) with regards to sleep quality and alveolar ventilation in patients with routine NIV initiation after COPD exacerbation.
20 patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP-ST) and one with the advanced mode of intelligent volume assured pressure support (iVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. Besides the number of arousals and PCO2 values over night the sleep quality will be judged with regards to especially adjusted respiratory event criteria like unintentional leaks, patient ventilator asynchrony, and decrease of ventilatory drive.
Detailed description
Non invasive ventilation (NIV) is one of the major medical innovations of the last 30 years. Especially continuous positive airway pressure (CPAP) is the established Gold Standard in obstructive sleep apnea (OSA) treatment.
NIV with bilevel ventilation (BiPAP-ST) is the established Gold Standard in acute hypercapnic respiratory failure, especially in exacerbated COPD.
Still, the adaption of CPAP in OSA is less complicated than a bilevel therapy in hypercapnic failure. The adjustment of NIV requires not only the definition of expiration pressure (PEEP) but also of inspiration pressure support. Only adequate pressure difference guarantees effective ventilatory assistance and an improvement of alveolar ventilation. The pressure changes need to be defined by the physician, as well as the breathing frequency.
Ventilation can furthermore be controlled by a target volume (volume controlled) or a target pressure (pressure controlled).
Moreover, patients with respiratory insufficiency are often suffering of significant dyspnoea and are hard to accustom to a respiratory mask.
There is a lack of systematic studies addressing the effects of different ventilator settings on sleep and life quality, as well as studies about the necessary monitoring extent during the NIV initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIPAP ST | Active comparator | Device: pressure controlled ventilation BIPAP ST, Device: NIVone night, NIV with pressure controlled ventilation (BIPAP ST) with individually titrated pressure parameters. |
| IVAPS | Experimental | Device: volume assured pressure support IVAPS, Device: NIVone night, NIV with volume assured pressure support (IVAPS).The pressure parameters will be adjusted according to the BIPAP pressure levels. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable respiratory insufficiency
- Hypercapnia >50 mmHG
- Clinically required NIV
- Capable of giving consent
Key exclusion criteria (8 listed)
- Existing ventilatory support
- 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)
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 |
|---|---|---|
| pressure controlled ventilation BIPAP STAlso: Stellar™ 150, ResMedspontaneous timed pressure controled bilevel ventilation | Device | BIPAP ST |
| volume assured pressure support IVAPSAlso: Stellar™ 150 with iVAPSintelligent volume assured Pressure Support | Device | IVAPS |
| NIVAlso: Stellar™ 150, ResMedPatients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP ST) and one with the advanced mode of intelligent volume assured pressure support (IVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement. | Device | BIPAP ST, IVAPS |
Primary outcome
Number of respiratory events during non invasive ventilation
Time frame: 2 nights
Unintentional leak, patient ventilator asynchrony, decrease of ventilatory drive, Apnoea, Hypopnea
1 secondary outcome
Sleep efficiency
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 24 Mar 2015.
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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 volume assured pressure support IVAPS and NIV in people with COPD and Chronic 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 4 inclusion and 8 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 24 Mar 2015. 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?
Number of respiratory events during non invasive ventilation (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 24 Mar 2015.