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

JRCT ID: jRCTs051220017

Registered date:01/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ARDS
• Date of first enrollment: 01/05/2022
• Target sample size: 25
• Study type: Interventional

Intervention(s)

Connect a simple vaporizer AnaConDa between the intubation tube and the Y piece of the respiratory circuit. Connect a syringe filled with liquid sevoflurane to the AnaConDa with the connecting tubing. The inhaled anesthetic vaporized in the AnaConDa is inhaled into the patient lung. Ninety percent of the sevoflurane in the patient's exhaled air is collected in the AnaConDa for reuse, and 10 percent is exhausted from the ventilator and adsorbed by activated carbon.
The concentration of exhaled anesthetic is monitored by an anesthetic concentration monitoring device connected to the ACD by a tube. When the exhaled sevoflurane concentration is stable, check the RASS score and adjust the sevoflurane dosing rate to achieve a RASS of -2 to -3.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Mizobuchi Satoshi