Respiratory FailureNCT00366912
Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode
A study testing non-invasive ventilation in people with Respiratory Failure, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
Trial summary
Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation. The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- non-invasive ventilation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Apr 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy voluntary individuals
- PFT within normal limits
Who cannot join
- Disease of the upper GI-tract
- Any form of lung disease or disease of the upper airways
- Any form of muscular disease, especially neuromuscular disease pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fachkrankenhaus Kloster Grafschaft
Schmallenberg, North Rhine-Westphalia, 57392
About this study
Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation.
The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.
Read the detailed description
Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading.
A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements.
After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements.
This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.
- Conditions
- Respiratory Failure
- Being tested
- non-invasive ventilation
- Keywords
- work of breathing, pressure time product, muscle pressures
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing, pressure time product
Secondary outcomes (1)
comfort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startAug 2006
- Study completionApr 2007
Why it stopped: No longer recruiting: participants are no longer being recruited or enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Investigators
- Dominic Dellweg, M.D., Principal investigator, Fachkrankenhaus Kloster Grafschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366912
- Sponsor's protocol ID
- Aladin 2006
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2006
- Last updated
- 11 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode
- ClinicalTrials.gov ID
- NCT00366912
- Acronym / sponsor ID
- Aladin 2006
- Conditions
- Respiratory Failure
- Keywords
- work of breathing, pressure time product, muscle pressures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer recruiting: participants are no longer being recruited or enrolled
- Enrolment
- 10 participants
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Aug 2006 (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.
Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation.
The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.
Detailed description
Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading.
A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements.
After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements.
This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy voluntary individuals
- PFT within normal limits
Key exclusion criteria (3 listed)
- Disease of the upper GI-tract
- Any form of lung disease or disease of the upper airways
- Any form of muscular disease, especially neuromuscular disease pregnancy
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 ventilation | Device | – |
Primary outcome
Work of breathing, pressure time product
1 secondary outcome
comfort
Results and safety
The study was stopped early (reason given: No longer recruiting: participants are no longer being recruited or enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
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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.
Dominic Dellweg, M.D. principal investigator
Fachkrankenhaus Kloster Grafschaft
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 Respiratory Failure, run by Krankenhaus Kloster Grafschaft 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 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: stopped early, as of the sponsor's last update on 11 Aug 2009. 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 was stopped early (reason given: No longer recruiting: participants are no longer being recruited or enrolled). 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?
Work of breathing, pressure time product. 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 Aug 2009; AzTrials last refreshed its copy on 7 Nov 2026.