RecruitingNot Applicable

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

Thailand214 participantsStarted 2023-12-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Successful extubation within 14 days after randomization

Timeframe: 14 days after randomization

Trial details

NCT IDNCT06203405

SponsorSiriraj Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Natdanai Ketdao, MD

+66880684998 natdke@kku.ac.th

View on ClinicalTrials.gov More Respiratory Failure trials