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

SMRG_318537

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.

2023-11-01

2024-12-31

2025-03-31

Recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, cross-over trial design comparing intravenous versus inhaled volatile sedation', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None, open label, physiological study'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-03-06