Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 17 and up

Investigating sedation methods for patients with Acute Respiratory Distress Syndrome on ventilators

Official title: Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome

Run by Guy's and St Thomas' NHS Foundation Trust · NCT06014138 · Data updated 2026-11-12

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.

More Acute Respiratory Distress Syndrome trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages17 Years and up
SexAll
Enrollment20 (estimated)
SponsorGuy's and St Thomas' NHS Foundation Trust
Academic / other
Locations1 site (London, London)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedJuly 31, 2027
Study endsJuly 31, 2027
Registry record updatedJune 4, 2026
Trial IDNCT06014138 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adult patients with Acute Respiratory Distress Syndrome who are on invasive mechanical ventilation and require sedation.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown promising results with inhaled sedation in similar patient populations, indicating potential benefits over traditional intravenous methods.

Who can join: the full rules

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 it's running

  • Guy's & St Thomas' NHS Foundation Trust
    London, London, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.