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

Phase 2

Recruiting

• Conditions: ARDS; ARDS, high tidal ventilation, propofol

• Registration Number: JPRN-jRCTs051220017
• Lead Sponsor: Mizobuchi Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

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

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 anaconda 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in tidal volume (mL/kg (predicted body weight)) between 6 hours after sevoflurane administration and baseline (immediately before sevoflurane change)<br>(Tidal volume is measured as an average per hour)