Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Vent… (NCT06242236) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)
Thailand156 participantsStarted 2023-10-01
Plain-language summary
The objective of this research is to utilize respiratory effort parameters as a tool to assist in adjusting sedative drug levels for patients undergoing mechanical ventilation in the intensive care unit, in comparison to the conventional usual care approach.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants must be aged between 18-75 years.
✓. Admitted to the critical care and semi-critical care units (ICUs) of the Department of Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
✓. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:
✓. Permission obtained from the attending physician.
✓. Research participants or their direct relatives must sign informed consent.
✓. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.
✓. Indicate for receiving sedative drugs during an invasive mechanical ventilator include situations such as when the patient experiences pain or agitation after the placement of the breathing assistance device or when there is patient-ventilator asynchrony.
Exclusion criteria
✕. Admitted to the hospital or had a history of hospital admission within a month before recruitment.
✕. History of cardiovascular or cerebrovascular events within the last 12 months.
✕. Allergic to sedative drugs used in the study.
✕. Pregnant.
✕. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
What they're measuring
1
28 days ventilator-free day
Timeframe: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.