Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE) (NCT04089111) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)
Turkey (Türkiye)20 participantsStarted 2024-12
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Restrictive lung pathologies
* Impaired hemodynamic status
* Esophageal pathologies
* Bronchopleural fistula
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — can you find out when it's expected to open, and whether it would even make sense to wait for it given where I am in my treatment right now?
2The trial is measuring something called transpulmonary inspiratory pressure — can you explain what that means for my lungs, and why controlling it might matter for someone with COPD who needs mechanical ventilation?
3Since this study is listed as Phase NA, which often means it's a device or procedure study rather than a drug trial, can you help me understand what 'closed loop ventilation' actually involves and what the risks of this approach might be compared to standard mechanical ventilation?
4This trial seems to focus on patients receiving mechanical ventilation — is that a situation I'm at risk of facing, and if so, is this the kind of research that could be relevant to my care plan?
5Are there already established ventilation strategies for COPD patients that my care team uses, and how does what this trial is testing compare to what I would receive as standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transpulmonary inspiratory pressure (Ptinsp)
Timeframe: 30'th minute of each intervention arm
Trial details
NCT IDNCT04089111
SponsorIzmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital