NCT06203405 The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
| NCT ID | NCT06203405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Siriraj Hospital |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2023-12-22 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 214 participants in total. It began in 2023-12-22 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and arousal level compared with conventional sedation strategy (targeting arousal level alone) in patients requiring mechanical ventilation in the medical intensive care unit.
Eligibility Criteria
Inclusion Criteria: 1. Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital 2. Age ≥18 years old 3. Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission) Exclusion Criteria: 1. Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients 2. Patients receiving mechanical ventilation for \>72 hours before enrollment 3. Patients receiving neuromuscular blocking agents prior to randomization 4. Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy 5. Patients with severe metabolic acidosis (arterial pH \<7.2) who do not have a plan for renal replacement therapy 6. Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases 7. Post-cardiac arrest patients 8. Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C 9. Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs 10. Pregnancy 11. Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments 12. Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment
Contact & Investigator
Tanuwong Viarasilpa, MD
PRINCIPAL INVESTIGATOR
Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
Frequently Asked Questions
Who can join the NCT06203405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06203405 currently recruiting?
Yes, NCT06203405 is actively recruiting participants. Contact the research team at natdke@kku.ac.th for enrollment information.
Where is the NCT06203405 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT06203405 clinical trial?
NCT06203405 is sponsored by Siriraj Hospital. The principal investigator is Tanuwong Viarasilpa, MD at Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University. The trial plans to enroll 214 participants.