The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Respiratory Failure, Critical Illness, Respiratory Distress Syndrome, Adult, Lung Injury, Mechanical Ventilation Complication
In brief
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.
Key facts
- Study ID
- NCT06203405
- Run by
- Siriraj Hospital
- People needed
- 214
- Starts
- 2023-12-22
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital
- Age ≥18 years old
- Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)
You may not qualify if…
- Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients
- Patients receiving mechanical ventilation for >72 hours before enrollment
- Patients receiving neuromuscular blocking agents prior to randomization
- Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy
- Patients with severe metabolic acidosis (arterial pH <7.2) who do not have a plan for renal replacement therapy
- Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases
- Post-cardiac arrest patients
- Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C
- Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs
- Pregnancy
- Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
- Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment
Where it is running
- Siriraj Hospital — Bangkok, Bangkok, Thailand (enrolling)
Full record on ClinicalTrials.gov
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