Using respiratory effort to guide sedation levels in ventilated patients

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

This study is testing if using breathing effort to adjust sedation levels can help patients on ventilators feel better compared to the usual care they receive.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ramathibodi Hospital (Academic / other)
• Locations: 1 site (Ratchathewi, Bangkok)
• Trial ID: NCT06242236 on ClinicalTrials.gov

What this trial studies

This research aims to compare the effectiveness of using respiratory effort parameters to adjust sedative drug levels in mechanically ventilated patients against the usual care approach. Participants will be screened daily in the intensive care unit and semi-intensive care unit, and those who meet the inclusion criteria will be randomly assigned to either the intervention group or the control group. The intervention group will have their sedation levels guided by measurements of respiratory effort, while the control group will receive standard care adjustments made by physicians. Informed consent will be obtained from the relatives of participants due to their altered state of awareness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who are admitted to critical care units with acute respiratory failure requiring mechanical ventilation.

Not a fit: Patients who are not mechanically ventilated or those with conditions that do not require sedation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective sedation management and improved outcomes for patients on mechanical ventilation.

How similar studies have performed: While the specific approach of using respiratory effort to guide sedation is novel, similar studies have shown promise in improving patient outcomes in mechanically ventilated patients.

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.

Where this trial is running

Ratchathewi, Bangkok

• Critical care medicine Ramathibodi hospital, 270 Rama 6 Rd. Phayatai — Ratchathewi, Bangkok, Thailand (Recruiting)

Study contacts

• Study coordinator: phruet Soipetkasem, MD

Conditions ARDS; Respiratory Effort; Mechanical Ventilation Complication; Sedation; Acute respiratory distress syndrome; Dynamic transpulmonary pressure swing; Patient self-inflicted lung injury; Patient ventilator asynchrony