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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

214 Participants
are divided into 2 treatment groups

Sponsors and collaborators