Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome (NCT06014138) | Clinical Trial Compass
RecruitingPhase 2/3
Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome
United Kingdom20 participantsStarted 2023-11-01
Plain-language summary
This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.
Who can participate
Age range
17 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:
* Adult patients admitted to the Intensive Care Unit (ICU)
* ARDS
* Invasive mechanical ventilation (IMV)
* Spontaneous breathing in pressures support mode (PSV) for less than or equal to 48 hours
* Sedated with intravenous sedation (ie. propofol and / or midazolam and fentanyl or alternate short acting opioid)
* Anticipated to remain on IMV and PSV and with a stable sedation score for a further 24 hours without planned sedation interruption / spontaneous breathing trial or other significant change in the level of ventilator support
* Not receiving / anticipated to receive paralysis
* In supine position
Exclusion Criteria:
* Personal or family history of malignant hyperpyrexia
* Known or suspected elevated intracranial pressure
* High dose vasopressors (ie. Noradrenaline \> 0.3mcg/kg/min or equivalent)
* Contra-indication to oesophageal balloon (i.e. oesophageal / upper gastro-intestinal pathology)
* Pregnancy
* High dose oral sedatives (e.g. benzodiazepines) or opioids (e.g. oxycodone / oral morphine) which may affect respiratory drive
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 testing volatile anesthetic gases as a sedation method for people on ventilators with ARDS — how does that compare to the standard intravenous sedation I'd normally receive in the ICU, and what are the main reasons my team might prefer one over the other for my situation?
2The trial is measuring something called respiratory drive, or P0.1 — can you explain what that means for my lungs, and why controlling it matters for how well I might recover from ARDS?
3Since this is a Phase 2/3 trial, there's still some uncertainty about how safe and effective volatile sedation is compared to usual care — what does that mean for my personal risk if I were to consider participating?
4ARDS can change quickly and ICU care is very intensive — what would participating in this study actually look like day to day, and would it change anything about how my sedation or ventilator settings are managed?
5Are there standard sedation approaches already proven to help ARDS patients that I should consider before thinking about whether this trial might be worth discussing with you?
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.