Evaluating a new sedation protocol for critically ill patients on mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the efficacy of a sedation protocol that targets optimal respiratory drive using P0.1 and arousal level in critically ill patients requiring mechanical ventilation. Patients will be randomized into two groups: one receiving the new sedation approach and the other following a conventional sedation strategy. The study aims to determine if the new protocol improves patient outcomes compared to traditional methods. Monitoring will include arousal levels and respiratory drive throughout the study period.

Why it matters

Who can join: the full rules

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

Where it's running

• Siriraj Hospital
  Bangkok, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Tanuwong Viarasilpa, MD — Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
• Study coordinator: Natdanai Ketdao, MD
• Email: natdke@kku.ac.th
• Phone: +66880684998

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.