Pulmonary Disease, Chronic ObstructivePhase 4NCT00969605
Adaptive Support Ventilation in the Weaning of COPD
A Phase 4 study testing Comparison of two different modes for weaning from mechanical ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Comparison of two different modes for weaning from mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 4
- 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
- Diagnosis of COPD
- On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure
Who cannot join
- Mechanical ventilation less then 24 hours (self extubation or death),
- Having a tracheotomy and
- COPD coexisted with severe cardiac or neurologic diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Izmir, 35210
About this study
Official title: Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Comparison of two different modes for weaning from mechanical ventilation
- Keywords
- weaning, adaptive support ventilation, COPD
- 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.
Comparison of two different modes for weaning from mechanical ventilationProcedure or surgery
Also called weaning protocol
Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.
| Study group | Role | What they receive |
|---|---|---|
| Pressure support ventilation | Active comparator | Not described Receives: Procedure: Comparison of two different modes for weaning from mechanical ventilation |
| Adaptive support ventilation | Active comparator | Not described Receives: Procedure: Comparison of two different modes for weaning from mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning duration
Secondary outcomes (2)
Weaning success
Length of stay in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Cenk Kirakli, MD, Study director, Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969605
- Sponsor's protocol ID
- IGCEH-ICU-1
- Status last verified
- Sep 2009
- First submitted
- 31 Aug 2009
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00969605
- Acronym / sponsor ID
- IGCEH-ICU-1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- weaning, adaptive support ventilation, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Sep 2009 (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.
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support ventilation | Active comparator | Procedure: Comparison of two different modes for weaning from mechanical ventilation |
| Adaptive support ventilation | Active comparator | Procedure: Comparison of two different modes for weaning from mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of COPD
- On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure
Key exclusion criteria (3 listed)
- Mechanical ventilation less then 24 hours (self extubation or death),
- Having a tracheotomy and
- COPD coexisted with severe cardiac or neurologic diseases.
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 |
|---|---|---|
| Comparison of two different modes for weaning from mechanical ventilationAlso: weaning protocolChronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria. | Procedure or surgery | Adaptive support ventilation, Pressure support ventilation |
Primary outcome
Weaning duration
2 secondary outcomes
Weaning success
Length of stay in the ICU
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 27 May 2010.
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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.
Cenk Kirakli, MD study director
Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comparison of two different modes for weaning from mechanical ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 27 May 2010. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weaning duration. 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 27 May 2010.