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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
Guy's & St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
How to Get in Touch
Guy Glover
Sponsor contactCONTACT
Gill Radcliffe
Sponsor contactCONTACT
