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Looking for participantsPhase2/Phase3

Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

Sponsor: Guy's and St Thomas' NHS Foundation Trust

NCT ID: NCT06014138

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Propofol (drug), Isoflurane (drug)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
Propofol — drug: Standard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation · Isoflurane — drug: Inhaled volatile sedation for 6 hours - 2 hours wash in / wash out, followed by 4 hours of observations
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
17 Years and over
Who
All
Number of participants
20
Started
2023-11-01
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for acute respiratory distress syndrome
  • • Phase2/Phase3 - 20 participants
  • • 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)

Who can take part?

  • • Ages 17 Years and over
  • • Diagnosed with acute respiratory distress syndrome

Where?

  • • London - Guy's & St Thomas' NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

It is routine for patients to be sedated for their comfort and safety whilst on a ventilator in the Intensive Care Unit (ICU). Conventionally sedatives are given intravenously, however inhaled volatile sedation is becoming more popular. Inhaled sedation has recently been approved by the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom (UK). Whilst being on a ventilator can be life-saving, it can cause potential problems. It is important that the patient interacts well with the ventilator and that their own breathing efforts are well regulated. There is evidence that inhaled sedation can specifically help the lungs when patients have the Acute Respiratory Distress Syndrome (ARDS) and in particular, inhaled sedation does not appear to suppress patient's own breathing as much as conventional sedation. Greater spontaneous breathing by the patient is usually positive but needs to be carefully understood to ensure it is not excessive or damaging to the patient's already injured lungs. This study of 20 patients is designed to carefully measure the impact of inhaled sedation on the patient's breathing and lung function, in comparison to intravenous sedation. Measurements will be taken whilst on intravenous sedation before the patient is switched to an equivalent level of inhaled sedation for six hours, when the measurements will be repeated. Finally, the patient will go back to their original intravenous sedation and the measurements taken again. This is called a 'cross-over' study and is a good way to evaluate the effect of the drug.

Acute Respiratory Distress SyndromeMechanical Ventilation ComplicationSedation Complication

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 17 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Adult patients admitted to the Intensive Care Unit (ICU)
  • ✓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)
  • ✓Not receiving / anticipated to receive paralysis

Who cannot take part

  • ✗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
See the full 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 Is This Study? (1 UK site)

Guy's & St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Guy Glover

Sponsor contact

CONTACT

00447879696250 guy.glover@gstt.nhs.uk

Gill Radcliffe

Sponsor contact

CONTACT

02071887188 gillian.radcliffe@gstt.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-06