Respiratory FailurePhase 4NCT01472302
Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
A Phase 4 study testing Adaptive Support Ventilation in people with Respiratory Failure and All Intubated Patients, 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 like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Respiratory Failure, All Intubated Patients
- What is being tested?
- Adaptive Support Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2012to Jan 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated and mechanically ventilated ICU patients for more than 24 hours
Who cannot join
- Patient with a tracheostomy
- Patients under home mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Izmir, Yenisehir, 35550
About this study
Official title: Effect of a Closed Loop Ventilation Strategy on Reducing the Total Duration of Mechanical Ventilation of Intubated Intensive Care Unit Patients: A Randomized Controlled Trial
Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV
- Conditions
- Respiratory Failure, All Intubated Patients
- Being tested
- Adaptive Support Ventilation, Pressure Controlled Ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Support VentilationDevice
Ventilation protocol according to the patients ideal body weight
Pressure Controlled VentilationDevice
Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU
| Study group | Role | What they receive |
|---|---|---|
| ASV | Experimental | Adaptive Support Ventilation Receives: Device: Adaptive Support Ventilation |
| PCV | Active comparator | Pressure Controlled Ventilation Receives: Device: Pressure Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 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
- Responsible party
- Principal investigator, Cenk Kirakli, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Investigators
- Cenk Kirakli, MD, Principal investigator, Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472302
- Sponsor's protocol ID
- IGCEAH-ICU 2
- Status last verified
- Mar 2014
- First submitted
- 11 Nov 2011
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.
PubMed 25742308
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Closed Loop Ventilation Strategy on Reducing the Total Duration of Mechanical Ventilation of Intubated Intensive Care Unit Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01472302
- Acronym / sponsor ID
- IGCEAH-ICU 2
- Conditions
- Respiratory Failure, All Intubated Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Nov 2011 (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 like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASV | Experimental | Device: Adaptive Support VentilationAdaptive Support Ventilation |
| PCV | Active comparator | Device: Pressure Controlled VentilationPressure Controlled Ventilation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intubated and mechanically ventilated ICU patients for more than 24 hours
Key exclusion criteria (2 listed)
- Patient with a tracheostomy
- Patients under home mechanical ventilation
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 |
|---|---|---|
| Adaptive Support VentilationVentilation protocol according to the patients ideal body weight | Device | ASV |
| Pressure Controlled VentilationVentilation protocol (6-8 ml/kg tidal volume) according to our ICU | Device | PCV |
Primary outcome
Duration of mechanical ventilation
Time frame: 1 year
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 6 Mar 2014.
- Derived from this study: PubMed 25742308Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.
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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 principal investigator
Izmir Dr. Suat Seren Chest Diseases and Surgery Training 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 Adaptive Support Ventilation in people with Respiratory Failure and All Intubated Patients, 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 1 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: finished, as of the sponsor's last update on 6 Mar 2014. 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?
Duration of mechanical ventilation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472302, which also lists 1 linked publication.
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 6 Mar 2014.