Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)

Launched by RAMATHIBODI HOSPITAL · Jan 28, 2024

Keywords

ClinConnect Summary

The EFFORT-GUIDE Trial 2 is a study that aims to find out if using a patient's breathing effort can help doctors better manage the amount of sedation given to patients on mechanical ventilation in the intensive care unit (ICU). Mechanical ventilation is a method to help patients breathe when they can't do so on their own, often due to serious conditions like acute respiratory distress syndrome (ARDS). This trial compares the new method of adjusting sedation based on how hard a patient is breathing to the usual way doctors manage sedation without this guidance.

To participate in the trial, patients need to be between 18 and 75 years old and admitted to specific ICU units at Ramathibodi Hospital due to severe breathing problems. They should be receiving mechanical ventilation within the first 48 hours of their admission. Participants will need to give consent, and their family members can help with this if necessary. The study will monitor how well the new sedation method works and if it improves patient care. If you or a loved one meet the criteria, joining this trial could contribute to better treatment for future patients in similar situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must be aged between 18-75 years.
• • 2. Admitted to the critical care and semi-critical care units (ICUs) of the Department of Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
• 3. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:
• • PaO2/FiO2 greater than 150 or
• • PaO2 less than 60 mm Hg or
• • SaO2 less than 90 mm Hg or
• • Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance
• • 4. Permission obtained from the attending physician.
• • 5. Research participants or their direct relatives must sign informed consent.
• • 6. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.
• • 7. 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:
• • 1. Admitted to the hospital or had a history of hospital admission within a month before recruitment.
• • 2. History of cardiovascular or cerebrovascular events within the last 12 months.
• • 3. Allergic to sedative drugs used in the study.
• • 4. Pregnant.
• • 5. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
• • 6. Active neurological or muscular disorders affecting stability.
• • 7. Brain coma, brain death, or status epilepticus.
• • 8. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia.
• • 9. Uncontrolled thyroid conditions within a month before recruitment.
• • 10. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150).
• • 11. Patients receiving neuromuscular blocking agents.