Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age17+
SponsorGuy's and St Thomas' NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Conventional intravenous sedationActive comparator 1 intervention
Group B: Inhaled volatile sedationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Respiratory drive (P0.1)

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

Time frame
8 hours

Secondary outcomes

1

Respiratory effort (Pmus)

End expiratory occlusion pressure (Pmus) - Physiological parameter

Time frame
8 hours
2

Respiratory effort (PMI)

Pressure Muscle Index (PMI) - Physiological parameter

Time frame
8 hours
3

Respiratory effort (Oesophageal pressure swings)

Oesophageal pressure swings - Physiological parameter

Time frame
8 hours
4

Gas exchange (PaO2:FiO2 ratio)

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

Time frame
8 hours

Other outcomes

Sponsors and contacts

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