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NCT Number: NCT06014138

Volatile Sedation 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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location status: Recruiting

Location contact

Gill Radcliffe

CONTACT

[email protected]

02071888070

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Respiratory drive (P0.1)

    Time frame: 8 hours

    Negative pressure in the first 100milliseconds of inspiration (P0.1) - Physiological parameter

Secondary outcomes

  1. Respiratory effort (Pmus)

    Time frame: 8 hours

    End expiratory occlusion pressure (Pmus) - Physiological parameter

  2. Respiratory effort (PMI)

    Time frame: 8 hours

    Pressure Muscle Index (PMI) - Physiological parameter

  3. Respiratory effort (Oesophageal pressure swings)

    Time frame: 8 hours

    Oesophageal pressure swings - Physiological parameter

  4. Gas exchange (PaO2:FiO2 ratio)

    Time frame: 8 hours

    Ratio of arterial partial pressure of oxygen to fractional inspired concentration of oxygen (PaO2:FiO2) - Physiological parameter

  5. Gas exchange (pulmonary shunt fraction (Qs/Qt))

    Time frame: 8 hours

    Pulmonary shunt fraction (Qs/Qt) - Physiological parameter

  6. Gas exchange ( ratio of ventilatory 'dead space' to tidal volume (Vd/Vt))

    Time frame: 8 hours

    ratio of ventilatory 'dead space' to tidal volume (Vd/Vt) - Physiological parameter

  7. Gas exchange (volume of carbon dioxide breathed out (VCO2))

    Time frame: 8 hours

    volume of carbon dioxide breathed out (VCO2) - Physiological parameter

Study contacts

Contact information is provided by the study sponsor or research team.

Gill Radcliffe

CONTACT

[email protected]

02071887188

Guy Glover

CONTACT

[email protected]

00447879696250

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Sedana Medical

Registry information

Official study title

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

Acronym: ISO-DRIVE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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