Chronic Obstructive Pulmonary DiseaseCOPD-SAFENCT04089111
Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)
A study testing Minute volume target of 100% and Minute volume target to reach PaCO2 less than 45% (high tidal volume) 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 evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Minute volume target of 100% and Minute volume target to reach PaCO2 less than 45% (high tidal volume)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Acute exacerbation of Chronic Obstructive Lung Disease
- Being intubated for less than 24 hours
- Not being planned to be extubated in 24 hours
- Expiratory time constant (RCexp) more than > 2.0 s
Who cannot join
- Restrictive lung pathologies
- Impaired hemodynamic status
- Esophageal pathologies
- Bronchopleural fistula
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Izmir, Yenisehir, 35550
About this study
Official title: Does Automatically Generated Tidal Volumes With Closed-loop Ventilation Leads to Safe Transpulmonary Pressures in Intubated Chronic Obstructive Pulmonary Disease Patients?
This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.
Read the detailed description
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) may require mechanical ventilation. Various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. High tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. Adapted Support Ventilation (ASV) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. Led by measured lung mechanics, ASV mode often generates higher than usual tidal volumes during mechanical ventilation of COPD patients, particularly if the minute volume (MV) target is high. Thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (Ptp), and whether Ptp stays within safe limits during ASV mode is of great interest.
Patients with acute exacerbation of COPD who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. All patients will be deeply sedated. An esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight.
Patients will be ventilated with two different MV targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively within each set. While the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients PaCO2 below 45 mmHg. The sequence of ventilation mode will be randomized within each set. Ventilation periods will be 30 minutes with 15 minutes washout period in between. İf Ptp increase above 20 cmH20 at any ventilation mode, the tidal volume will be decreased.
ASV mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Minute volume target of 100%, Minute volume target to reach PaCO2 less than 45% (high tidal volume)
- Keywords
- Mechanical ventilation, Adaptive Support Ventilation, Transpulmonary pressure, Intrinsic PEEP, Safety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Positive-Pressure Respiration, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minute volume target of 100%Other
Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight).
Minute volume target to reach PaCO2 less than 45% (high tidal volume)Other
Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%.
| Study group | Role | What they receive |
|---|---|---|
| 1.1. ASV, MV target 100% | Experimental | Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator. Receives: Other: Minute volume target of 100% |
| 1.2. Volume control, MV target %100 | Active comparator | Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3 Ventilation frequency will be adjusted to reach the same volume target calculated in arm1. Receives: Other: Minute volume target of 100% |
| 2.1. ASV, MV target to reach PaCO2< 45 mmHg | Experimental | Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator. Receives: Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume) |
| 2.2. Volume control, MV target to reach PaCO2< 45 mmHg | Active comparator | Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3. Ventilation frequency will be adjusted to reach the target PaCO2 level Receives: Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary inspiratory pressure (Ptinsp)
Ptpinsp will be measured with an inspiratory pause maneuver.
Measured: 30'th minute of each intervention arm
Secondary outcomes (1)
Intrinsic Positive End Expiratory Pressure (PEEPi)
PEEPi will be measured with an expiratory hold maneuver.
Measured: 30'th minute of each intervention arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be ventilated for two different minute volume targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively in each set. Every patient will be ventilated 1.1. ASV with minute volume target of % 100; 1.2. VC with same MV target; 2.1 ASV with MV target associated with PaCo2 less than 45 mmHg; 2.2 VC with same MV target. Sequence of ventilation modes wıll be randomized within each group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- Sami C Kirakli, MD, Principal investigator, Dr. Suat Seren Chest Diseases and Surgery Educatin and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089111
- Sponsor's protocol ID
- IGHCEAH-ICU-4
- Acronym
- COPD-SAFE
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Grieco DL, Chen L, Brochard L. Transpulmonary pressure: importance and limits. Ann Transl Med. 2017 Jul;5(14):285. doi: 10.21037/atm.2017.07.22.
PubMed 28828360Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PubMed 27334266Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
PubMed 24467647
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Automatically Generated Tidal Volumes With Closed-loop Ventilation Leads to Safe Transpulmonary Pressures in Intubated Chronic Obstructive Pulmonary Disease Patients?
- ClinicalTrials.gov ID
- NCT04089111
- Acronym / sponsor ID
- COPD-SAFE / IGHCEAH-ICU-4
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Mechanical ventilation, Adaptive Support Ventilation, Transpulmonary pressure, Intrinsic PEEP, Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Sep 2019 (actual)
- 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 evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.
Detailed description
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) may require mechanical ventilation. Various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. High tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. Adapted Support Ventilation (ASV) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. Led by measured lung mechanics, ASV mode often generates higher than usual tidal volumes during mechanical ventilation of COPD patients, particularly if the minute volume (MV) target is high. Thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (Ptp), and whether Ptp stays within safe limits during ASV mode is of great interest.
Patients with acute exacerbation of COPD who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. All patients will be deeply sedated. An esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight.
Patients will be ventilated with two different MV targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively within each set. While the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients PaCO2 below 45 mmHg. The sequence of ventilation mode will be randomized within each set. Ventilation periods will be 30 minutes with 15 minutes washout period in between. İf Ptp increase above 20 cmH20 at any ventilation mode, the tidal volume will be decreased.
ASV mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be ventilated for two different minute volume targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively in each set. Every patient will be ventilated 1.1. ASV with minute volume target of % 100; 1.2. VC with same MV target; 2.1 ASV with MV target associated with PaCo2 less than 45 mmHg; 2.2 VC with same MV target. Sequence of ventilation modes wıll be randomized within each group.
| Arm | Type | Receives |
|---|---|---|
| 1.1. ASV, MV target 100% | Experimental | Other: Minute volume target of 100%Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator. |
| 1.2. Volume control, MV target %100 | Active comparator | Other: Minute volume target of 100%Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3 Ventilation frequency will be adjusted to reach the same volume target calculated in arm1. |
| 2.1. ASV, MV target to reach PaCO2< 45 mmHg | Experimental | Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume)Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator. |
| 2.2. Volume control, MV target to reach PaCO2< 45 mmHg | Active comparator | Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume)Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3. Ventilation frequency will be adjusted to reach the target PaCO2 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute exacerbation of Chronic Obstructive Lung Disease
- Being intubated for less than 24 hours
- Not being planned to be extubated in 24 hours
- Expiratory time constant (RCexp) more than > 2.0 s
Key exclusion criteria (4 listed)
- Restrictive lung pathologies
- Impaired hemodynamic status
- Esophageal pathologies
- Bronchopleural fistula
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 |
|---|---|---|
| Minute volume target of 100%Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight). | Other | 1.1. ASV, MV target 100%, 1.2. Volume control, MV target %100 |
| Minute volume target to reach PaCO2 less than 45% (high tidal volume)Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%. | Other | 2.1. ASV, MV target to reach PaCO2< 45 mmHg, 2.2. Volume control, MV target to reach PaCO2< 45 mmHg |
Primary outcome
Transpulmonary inspiratory pressure (Ptinsp)
Time frame: 30'th minute of each intervention arm
Ptpinsp will be measured with an inspiratory pause maneuver.
1 secondary outcome
Intrinsic Positive End Expiratory Pressure (PEEPi)
Time frame: 30'th minute of each intervention arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Background: PubMed 28828360Grieco DL, Chen L, Brochard L. Transpulmonary pressure: importance and limits. Ann Transl Med. 2017 Jul;5(14):285. doi: 10.21037/atm.2017.07.22.
- Background: PubMed 27334266Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
- Background: PubMed 24467647Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
- Individual participant dataSharing planned: No
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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.
Sami C Kirakli, MD principal investigator
Dr. Suat Seren Chest Diseases and Surgery Educatin and Resarch 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 Minute volume target of 100% and Minute volume target to reach PaCO2 less than 45% (high tidal volume) 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami C Kirakli, MD (+905052352024, samicenk.kirakli@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transpulmonary inspiratory pressure (Ptinsp) (time frame: 30'th minute of each intervention arm). 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 NCT04089111, which also lists 4 linked publications.
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 15 Oct 2024.