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The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial

RecruitingNAAges 18 Years - anyAllSiriraj Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital 2. Age โ‰ฅ18 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
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What it tests

  • Titrating sedation targeting both optimal P0.1 and appropriate arousal level
  • Fentanyl
  • Midazolam
  • Propofol
  • Dexmedetomidine
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Where

1 site
Siriraj Hospital
Bangkok, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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