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Prospective Observational Pilot Study to Evaluate the Effect of Sevoflurane in ARDS patients

Prospective Observational Pilot Study to Evaluate the Effect of Sevoflurane in ARDS patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051220017
Enrollment
25
Registered
2022-05-01
Start date
2025-01-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS ARDS, high tidal ventilation, propofol

Interventions

Connect a simple vaporizer SedaConDa between the intubation tube and the Y piece of the respiratory circuit. Connect a syringe filled with liquid sevoflurane to the SedaConDa with the connecting tubin
sevoflurane

Sponsors

Obata Norihiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients admitted to ICU 2. patients aged 20 years or older at the time of consent 3. more than 48 hours but less than 1 week after onset of ARDS 4. patients on ventilator who are sedated with propofol 5. Patients that an average of one hour of spontaneous respiratory volume was 10 ml/kg (predicted body weight*) or more even for more than 1 hour even using a maximum dose of 3 mg/kg/h of propof ol.Predicted weight: Male: 50.0 + 0.91 x (height - 152.4 (cm)), Female: 45.5 + 0.91 x (height - 152.4 (c m)) 6. Patients who will be on a ventilator for more than 48 hours after enrollment in the study. 7. Patients who have given written explanation of this study to the patient or the substitute, and have obtained written consent from the patient or the substitute.

Exclusion criteria

Exclusion criteria: 1. Patients with jaundice or unexplained fever after previous use of halogenated anesthetics 2. patients with a history of hypersensitivity to anycomponent of sevoflurane 3. patients with clinical evaluation of intracranial hypertension or possible intracranial hypertension 4. patients with a history or family history of malignant hyperthermia 5. patients with muscular dystrophy, central core disease, multimini core disease, King Denborough s yndrome 6. patients with a history of epilepsy 7. patients with trauma to the trunk 8. patients with hepatic insufficiency (serum total bilirubin > 2 mg/dL within 2 days of enrollment) 9. Patients with renal failure (serum creatinine > 2mg/dL within 2 days of enrollment) 10. Patients with anticipated sedaconda ACD-S obstruction due to excessive secretions 11. patients with known pregnancy 12. patients with acute SARS-Cov-2 infection 13. patients who are judged as inappropriate by the person in charge of this study

Design outcomes

Primary

MeasureTime frame
Change in tidal volume (mL/kg (predicted body weight)) between 6 hours after sevoflurane administration and baseline (immediately before sevoflurane change) (Tidal volume is measured as an average per hour)

Secondary

MeasureTime frame
Efficacy endpoints 1) Changes in respiratory mechanics over time Tidal voume at each time point (Tidal volume is measured as an average per hour) Transpulmonary pressur Plateau pressure Airway occlusion pressure Pressure-time products PaO2/FIO2 Static compliance (inspiratory volume/(plateau pressure - PEEP)) Dynamic compliance (inspiratory volume/(maximal airway pressure - PEEP)) Airway resistance (maximal airway pressure - plate au pressure) / inspiratory flow velocity) Evaluation of lung hyperinflation and collapse by electrical impedance tomography 2) Changes in values indicating anti-inflammatory effects Blood leukocyte count and fractionation Serum C-reactive protein Serum cytokines (interleukin-1beta,6,8, Tumor necrosis factor-arufa) Serum RAGE (soluble receptor for advanced glycation end products) Safety evaluation indices The following items will be recorded during propof ol and sevoflurane administration. (1) Sedation level;RASS (Richmond Agitation-Sedation Scale) score (2) State of Analgesia C-POT (Critical-Care Pain Observation Tool) score (3) State of Delirium ICDSC (Intensive Care Delirium Screening Check list) score (4) Mean arterial pressure and pulse rate (5) Presence of malignant hyperthermia (6) Drug dosage (sevoflurane dosage rate and expiratory concentration, fentanyl dosage rate, de xmedetomidine administration rate) (7) Endtidal CO2 pressure at the time of sevoflurane administration (8) Occurrence of new diseases. (9) Occurrence of failure of device (10) Dosage of dexmedetomidine, haloperidol, atypical antipsychotics

Contacts

Public ContactNorihiko Obata

Kobe University Hospital

obatan@med.kobe-u.ac.jp+81-78-382-6172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026