Chronic Obstructive Pulmonary DiseaseNCT02651935
Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU
A study testing Intellivent ASV in people with Chronic Obstructive Pulmonary Disease, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Intellivent ASV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2015to Feb 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)
- Age > 18 years
- Written and/or informed consent
Who cannot join
- Septic shock
- Tracheostomy and/or home mechanical ventilation
- Expected poor short term prognosis
- Cardiac arrest with a poor neurological prognosis
- ARDS
- Broncho-pleural fistula
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: A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients
This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.
Read the detailed description
COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Intellivent ASV
- Keywords
- Respiration, Artificial, weaning, critical care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellivent ASVDevice
Automated Invasive mechanical ventilation and weaning strategy
| Study group | Role | What they receive |
|---|---|---|
| Intellivent ASV | Experimental | Patients in this arm will be ventilated with Intellivent ASV. Intellivent ASV is an automatic close loop ventilation mode. FiO2 setting will be automatically adjusted according to patients SpO2 and minute volume will be automatically adjusted according to patients EtCO2. Receives: Device: Intellivent ASV |
| PCV+PSV | No intervention | PCV+PSV is a conventional ventilation strategy of pressure controlled ventilation PCV) and pressure support ventilation (PSV).In this arm, FiO2, pressure control levels, respiratory frequency and all the ventilator settings will be manually adjusted by the physicians in charge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intubation
Time from intubation until extubation
Measured: 24th month
Duration of mechanical ventilation (NIV included)
Total time patient remains on mechanical ventilation support (invasive or noninvasive)
Measured: 24th month
Secondary outcomes (4)
Number of manual settings
Number of adjusments made manually to set the ventilator
Measured: 24th month
Number of blood gas analysis tests
Number of arterial blood gas tests under mechanical ventilation
Measured: 24th month
Weaning duration
Time from the beginning of weaning until extubation
Measured: 24th month
Time spent on spontaneous ventilation
Time patient actively triggers the ventilator
Measured: 24th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 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, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Investigators
- Ilknur Naz, Principal investigator, Izmir Chest Diseases and Surgery Training HospitalBurcu CINLETI, Principal investigator, Izmir Chest Diseases and Surgery Training HospitalHuseyin OZKARAKAS, Principal investigator, Izmir Chest Diseases and Surgery Training HospitalTunzala YAVUZ, Principal investigator, Izmir Chest Diseases and Surgery Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651935
- Sponsor's protocol ID
- IGHCEAH-ICU-3
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2015
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients
- ClinicalTrials.gov ID
- NCT02651935
- Acronym / sponsor ID
- IGHCEAH-ICU-3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Respiration, Artificial, weaning, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 11 Jan 2016 (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.
This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.
Detailed description
COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intellivent ASV | Experimental | Device: Intellivent ASVPatients in this arm will be ventilated with Intellivent ASV. Intellivent ASV is an automatic close loop ventilation mode. FiO2 setting will be automatically adjusted according to patients SpO2 and minute volume will be automatically adjusted according to patients EtCO2. |
| PCV+PSV | No intervention | –PCV+PSV is a conventional ventilation strategy of pressure controlled ventilation PCV) and pressure support ventilation (PSV).In this arm, FiO2, pressure control levels, respiratory frequency and all the ventilator settings will be manually adjusted by the physicians in charge. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)
- Age > 18 years
- Written and/or informed consent
Key exclusion criteria (6 listed)
- Septic shock
- Tracheostomy and/or home mechanical ventilation
- Expected poor short term prognosis
- Cardiac arrest with a poor neurological prognosis
- ARDS
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 |
|---|---|---|
| Intellivent ASVAutomated Invasive mechanical ventilation and weaning strategy | Device | Intellivent ASV |
Primary outcome
Duration of intubation
Time frame: 24th month
Time from intubation until extubation
Duration of mechanical ventilation (NIV included)
Time frame: 24th month
Total time patient remains on mechanical ventilation support (invasive or noninvasive)
4 secondary outcomes
Number of manual settings
Time frame: 24th month
Number of blood gas analysis tests
Time frame: 24th month
Weaning duration
Time frame: 24th month
Time spent on spontaneous ventilation
Time frame: 24th month
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 29 Jul 2021.
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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.
Ilknur Naz principal investigator
Izmir Chest Diseases and Surgery Training Hospital
Burcu CINLETI principal investigator
Izmir Chest Diseases and Surgery Training Hospital
Huseyin OZKARAKAS principal investigator
Izmir 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 study testing Intellivent ASV in people with Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 6 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 29 Jul 2021. 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.
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 intubation (time frame: 24th month). The study lists 2 primary outcomes in all. 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 29 Jul 2021.