Status:
RECRUITING
Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
Sedana Medical
Conditions:
Acute Respiratory Distress Syndrome
Mechanical Ventilation Complication
Eligibility:
All Genders
17+ years
Phase:
PHASE2
PHASE3
Brief 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 w...
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 volatil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06014138
Start Date
November 1 2023
End Date
March 31 2025
Last Update
March 6 2024
Active Locations (1)
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1
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT