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Respiratory Effort Parameters-Guided Sedation in ARDS Patients After Discontinuation of Neuromuscular Blocking Agent or During Sedation Weaning: A Feasibility RCT

Respiratory Effort Parameters-Guided Sedation in ARDS Patients After Discontinuation of Neuromuscular Blocking Agent or During Sedation Weaning: A Feasibility RCT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251201005
Enrollment
30
Registered
2025-12-01
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory effort-guided sedation in patients with acute respiratory distress syndrome Acute respiratory distress syndrome, sedation, neuromuscular blocking agent, respiratory effort, respiratory drive

Interventions

At baseline, P0.1, predicted transpulmonary driving pressure (predicted delta PL), Pocc, vital signs, Richmond Agitation-Sedation Scale (RASS), and electrical impedance tomography (EIT) data are recor
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Respiratory effort-guided sedation,Sedation adjustment as usual care

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Mechanically ventilated patients meeting the Berlin definition of acute respiratory distress syndrome within 24 hours of intensive care unit admission 2. PaO2/FiO2 ratio of 150 mmHg or less within the first 24 hours after initiation of mechanical ventilation

Exclusion criteria

Exclusion criteria: 1. PaO2/FiO2 ratio of 150 mmHg or less after 48 hours of mechanical ventilation 2. Presence of bronchopleural fistula 3. Severe chronic lung disease, causing disability and requiring long-term home oxygen therapy 4. Pre-existing pulmonary hypertension 5. Presence of large intrathoracic mass 6. Contraindications to monitoring with electrical impedance tomography, such as chest wounds or burns, chest trauma, chest tube placement, or implanted electronic devices 7. Hemodynamic instability, defined as systolic blood pressure less than 80 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor support, and/or heart rate less than 55 bpm 8. Patients at risk of increased intracranial pressure or during post-cardiac arrest care 9. Neurologic disorders associated with impaired consciousness 10. Status epilepticus 11. Neuromuscular diseases 12. Pregnancy 13. Inability to perform electrical impedance tomography monitoring (for example, electrical impedance tomography device unavailable) 14. Patients not receiving full intensive care treatment or with an expected survival less than 24 hours 15. Presence of the other acute medical conditions, specifically thyroid storm, psychosis, and alcohol withdrawal 16. Bedridden patients 17. Advanced-stage malignancy 18. Patients receiving palliative care 19. Patients with a do-not-resuscitate (DNR) order 20. Refusal of participation by the attending intensivist or primary physician 21. Refusal of participation by the patient or the patient's legal representative

Design outcomes

Primary

MeasureTime frame
Successful weaning of sedation Day 3 Percentage of reduction in sedation dose; Richmond Agitation-Sedation Scale

Secondary

MeasureTime frame
Level of sedation Day 3 Richmond Agitation-Sedation Scale,Sedation dose Day 3 Milligram, microgram (per kilogram of body weight),Respiratory effort parameters Day 3 cmH2O,Desaturation Day 3 Number of events,Ventilator-free days Day 28 Number of days,Mortality Day 28 Number of deaths

Countries

Thailand

Contacts

Public ContactPongdhep Theerawit

Faculty of Medicine Ramathibodi Hospital, Mahidol University

pongdhep@yahoo.com6622010107

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026