Clinical trial

Effect of Inhalational Sedation on Mechanical Power in Mechanically Ventilated Patients: a Pilot Open-label Randomized Controlled Study

Name
385/2565(IRB2)
Description
Analgosedation is usually given to critically ill patients admitted in ICU. Fentanyl is the most common agent used for this purpose. For sedative agent, midazolam and propofol are commonly administered. However, too much sedation is apparently associated with increased duration of mechanical ventilation, prolonged ICU stay, and increased mortality. In mechanically ventilated patients, mechanical power is the respiratory mechanic that can predict clinical outcomes including mortality in both ARDS and non-ARDS patients. Previous study demonstrated that sedating mechanically ventilated patients with propofol could decreased mechanical power. This was possibly associated with improved clinical outcomes in these patients. At present, there is no clinical study investigating effects of inhalation sedation on mechanical power and clinical outcomes in mechanically ventilated patients.
Trial arms
Trial start
2022-11-15
Estimated PCD
2023-05-01
Trial end
2023-06-01
Status
Recruiting
Treatment
Inhalational sedation
Inhalational sedation with isoflurane for 12 hours
Arms:
Inhalational sedation
Convention sedation
Conventional sedation receiving analgosedation with fentanyl
Arms:
Conventional sedation
Size
40
Primary endpoint
Change in mechanical power
At 15 hours after intervention applied
Eligibility criteria
Inclusion Criteria: 1. Patient with age \>18 years old; and 2. Patient who is admitted to the participating ICU; and 3. Patient who receives respiratory support with invasive mechanical ventilation via endotracheal tube \< 12 hours prior to inclusion with anticipated duration of \> 48 hours Exclusion Criteria: 1. Patient with history or suspected history of malignant hyperthermia 2. Patient with evident or suspected increased intracranial pressure 3. Patient with high severity of illness whose ICU survival is not expected 4. Patient who refuses or patient whose proxy refuses to participate in the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-03-15

1 organization

2 products

5 indications

Organization
Mahidol University
Indication
Sedation
Indication
Lung Injury