Acute Respiratory Distress SyndromePhase 2/3ISO-DRIVENCT06014138
Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome
A Phase 2/3 study testing Propofol and Isoflurane in people with Acute Respiratory Distress Syndrome and Mechanical Ventilation Complication, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, Sedation Complication
- What is being tested?
- Propofol and Isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 31 Jul 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, London, SE1 9RT
Gill Radcliffe, 02071888070, gillian.radcliffe@gstt.nhs.uk
About this study
Official title: Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, Sedation Complication
- Being tested
- Propofol, Isoflurane
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Standard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation
IsofluraneDrug
Inhaled volatile sedation for 6 hours - 2 hours wash in / wash out, followed by 4 hours of observations
| Study group | Role | What they receive |
|---|---|---|
| Conventional intravenous sedation | Active comparator | Conventional intravenous sedation (e.g. propofol) with short acting opioid, titrated to a clinically prescribed sedation score. Period of observation will be 2 hours pre-cross over and 2 hours post cross over. Receives: Drug: Propofol |
| Inhaled volatile sedation | Active comparator | Inhaled volatile sedation (Isoflurane) delivered via the AnaConDa device for a 6 hour period (2 hours washout of intravenous sedation / wash-in of volatile to achieve stable baseline, followed by 4 hours of observations at steady state) titrated to an equivalent sedation score. During this period opioid infusion should be maintained at baseline level unless clinical indication for titration of dose. Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory drive (P0.1)
Negative pressure in the first 100milliseconds of inspiration (P0.1) - Physiological parameter
Measured: 8 hours
Secondary outcomes (7)
Respiratory effort (Pmus)
End expiratory occlusion pressure (Pmus) - Physiological parameter
Measured: 8 hours
Respiratory effort (PMI)
Pressure Muscle Index (PMI) - Physiological parameter
Measured: 8 hours
Respiratory effort (Oesophageal pressure swings)
Oesophageal pressure swings - Physiological parameter
Measured: 8 hours
Gas exchange (PaO2:FiO2 ratio)
Ratio of arterial partial pressure of oxygen to fractional inspired concentration of oxygen (PaO2:FiO2) - Physiological parameter
Measured: 8 hours
Gas exchange (pulmonary shunt fraction (Qs/Qt))
Pulmonary shunt fraction (Qs/Qt) - Physiological parameter
Measured: 8 hours
Gas exchange ( ratio of ventilatory 'dead space' to tidal volume (Vd/Vt))
ratio of ventilatory 'dead space' to tidal volume (Vd/Vt) - Physiological parameter
Measured: 8 hours
Gas exchange (volume of carbon dioxide breathed out (VCO2))
volume of carbon dioxide breathed out (VCO2) - Physiological parameter
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Nov 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Prospective, cross-over trial design comparing intravenous versus inhaled volatile sedation
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sedana Medical
- Responsible party
- Sponsor
- Investigators
- Guy Glover, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014138
- Sponsor's protocol ID
- SMRG_318537
- Acronym
- ISO-DRIVE
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No