Mechanical Ventilation Clinical Trial
Official title:
Effect of Inhalational Sedation on Mechanical Power in Mechanically Ventilated Patients: a Pilot Open-label Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mechanical power | Change in mechanical power from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied | |
Secondary | Change in oxygenation | Change in oxygenation from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied | |
Secondary | Change in respiratory mechanic | Change in respiratory mechanic from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied | |
Secondary | Change in serum interleukin 6 | Change in serum interleukin 6 from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied | |
Secondary | Change in serum C-reactive protein | Change in serum C-reactive protein from Phase 1 to Phase 2 compared between 2 groups | At 15 hours after intervention applied |
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