Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome

NCT06014138 | Recruiting Phase 2

• 1 other identifier: SMRG_318537
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Respiratory Distress Syndrome; Mechanical Ventilation Complication; Sedation Complication

Outcome Measures

Primary Outcomes (1)

• Respiratory drive (P0.1)

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

  8 hours

Secondary Outcomes (7)

• Respiratory effort (Pmus)

  8 hours

• Respiratory effort (PMI)

  8 hours

• Respiratory effort (Oesophageal pressure swings)

  8 hours

• Gas exchange (PaO2:FiO2 ratio)

  8 hours

• Gas exchange (pulmonary shunt fraction (Qs/Qt))

  8 hours

Study Arms (2)

Conventional intravenous sedation

ACTIVE COMPARATOR

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.

Drug: Propofol

Inhaled volatile sedation

ACTIVE COMPARATOR

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.

Drug: Isoflurane

Interventions

Propofol DRUG

Standard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation

Conventional intravenous sedation

Isoflurane DRUG

Inhaled volatile sedation for 6 hours - 2 hours wash in / wash out, followed by 4 hours of observations

Inhaled volatile sedation

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Sedana Medical: collaborator

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Propofol; Isoflurane

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers

Study Officials

• Guy Glover

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Glover

CONTACT

00447879696250; guy.glover@gstt.nhs.uk

Gill Radcliffe

CONTACT

02071887188; gillian.radcliffe@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None, open label, physiological study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, cross-over trial design comparing intravenous versus inhaled volatile sedation

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: August 28, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)