Actively Recruiting

Phase 2
Phase 3
Age: 17Years +
All Genders
ID06014138

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

Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2026-06-04

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Guy's and St Thomas' NHS Foundation Trust

Lead Sponsor

S

Sedana Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how different types of routine sedation affect breathing in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation in the Intensive Care Unit (ICU). The study compares inhaled volatile sedation, similar to anesthetic gases, with conventional intravenous sedation. This research aims to understand the impact of sedation methods on patients' breathing efforts and lung function, as well as how sedation influences interaction with the ventilator. Participants will receive both intravenous sedation (such as propofol) and inhaled volatile sedation (Isoflurane) delivered via the AnaConDa device. The study involves an initial 2-hour observation period on intravenous sedation, followed by a 6-hour period of inhaled sedation which includes 2 hours for washout and establishment, and 4 hours of observation. After this, patients will return to their original intravenous sedation for another 2-hour observation. Opioid infusion will be maintained at baseline levels during inhaled sedation unless clinical reasons require adjustment. During the study, researchers will closely monitor respiratory drive, breathing efforts, and lung function using several measures like respiratory effort and gas exchange parameters over an 8-hour period. Patients will be assessed while sedated and on mechanical ventilation, with attention to sedation scores and ventilatory support stability. The study is expected to continue until July 2027 and includes detailed monitoring to understand the effects of sedation type on breathing in ARDS patients.

CONDITIONS

Brief Title

Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

Who Can Participate

Age: 17Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients admitted to the Intensive Care Unit (ICU)
  • Diagnosis of Acute Respiratory Distress Syndrome (ARDS)
  • Receiving invasive mechanical ventilation (IMV)
  • Spontaneous breathing in pressure support mode (PSV) for 48 hours or less
  • Sedated with intravenous sedation such as propofol, midazolam, fentanyl, or another short acting opioid
  • Expected to remain on IMV and PSV with a stable sedation score for at least 24 hours without planned sedation interruption or major ventilator changes
  • Not receiving or expected to receive paralysis
  • Positioned in supine position
Not Eligible

You will not qualify if you...

  • Personal or family history of malignant hyperpyrexia
  • Known or suspected raised intracranial pressure
  • Receiving high dose vasopressors (e.g., Noradrenaline > 0.3mcg/kg/min or equivalent)
  • Contraindication to oesophageal balloon use due to oesophageal or upper gastrointestinal pathology
  • Pregnancy
  • Receiving high doses of oral sedatives (e.g., benzodiazepines) or opioids (e.g., oxycodone, oral morphine) that may affect respiratory drive

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 10 hours

Participants receive conventional intravenous sedation with propofol and then switch to inhaled volatile sedation with isoflurane for 6 hours, followed by a return to intravenous sedation. Measurements of breathing and lung function are taken throughout.

1 continuous in-ICU observation period

Trial Site Locations

Total: 1 location

1

Guy's & St Thomas' NHS Foundation Trust

London, London, United Kingdom, SE1 9RT

Actively Recruiting

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Research Team

G

Guy Glover

G

Gill Radcliffe

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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