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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 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
Participation Requirements
Sex: All
Minimum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Guy Glover
guy.glover@gstt.nhs.uk
00447879696250
Backup
Gill Radcliffe
gillian.radcliffe@gstt.nhs.uk
02071887188
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 20
Treatments
Active_comparator: Conventional intravenous sedation
Conventional intravenous sedation (e.g. propofol) with short acting opioid, titrated to a clinically prescribed sedation score. Period of observation will be 2 hours pre-cross over and 2 hours post cross over.
Active_comparator: Inhaled volatile sedation
Inhaled volatile sedation (Isoflurane) delivered via the AnaConDa device for a 6 hour period (2 hours washout of intravenous sedation / wash-in of volatile to achieve stable baseline, followed by 4 hours of observations at steady state) titrated to an equivalent sedation score. During this period opioid infusion should be maintained at baseline level unless clinical indication for titration of dose.
Sponsors
Collaborators: Sedana Medical
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov