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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Crossover
Treatments tested in this trial
Propofol
DrugStandard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation
Isoflurane
DrugInhaled volatile sedation for 6 hours - 2 hours wash in / wash out, followed by 4 hours of observations
Treatment groups
Trial outcomes
Primary outcomes
Respiratory drive (P0.1)
Negative pressure in the first 100milliseconds of inspiration (P0.1) - Physiological parameter
Secondary outcomes
Respiratory effort (Pmus)
End expiratory occlusion pressure (Pmus) - Physiological parameter
Respiratory effort (PMI)
Pressure Muscle Index (PMI) - Physiological parameter
Respiratory effort (Oesophageal pressure swings)
Oesophageal pressure swings - Physiological parameter
Gas exchange (PaO2:FiO2 ratio)
Ratio of arterial partial pressure of oxygen to fractional inspired concentration of oxygen (PaO2:FiO2) - Physiological parameter
Sponsors and contacts
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Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
Sedana Medical
Collaborator