Investigating sedation methods for patients with Acute Respiratory Distress Syndrome on ventilators
Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome
This study is testing whether using different sedation methods helps patients with Acute Respiratory Distress Syndrome on ventilators breathe better and feel more comfortable in the ICU.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06014138 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of different sedation methods on patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation in the Intensive Care Unit (ICU). It compares intravenous sedation with inhaled volatile sedation to assess their impact on breathing efforts and lung function. The study involves measuring patients' respiratory parameters while they receive both types of sedation, allowing researchers to determine which method better supports lung function and patient comfort. A total of 20 patients will participate, with careful monitoring of their sedation levels and breathing responses throughout the process.
Who should consider this trial
Good fit: Ideal candidates include adult patients with Acute Respiratory Distress Syndrome who are on invasive mechanical ventilation and require sedation.
Not a fit: Patients with contraindications to inhaled sedation or those with severe complications such as elevated intracranial pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sedation practices that enhance lung function and patient comfort during mechanical ventilation.
How similar studies have performed: Previous studies have shown promising results with inhaled sedation in similar patient populations, indicating potential benefits over traditional intravenous methods.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Guy Glover — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Guy Glover
- Email: guy.glover@gstt.nhs.uk
- Phone: 00447879696250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.