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The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Sponsor: Siriraj Hospital
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
214
Start Date
2023-12-22
Completion Date
2026-06-30
Last Updated
2025-05-22
Healthy Volunteers
No
Conditions
Interventions
Titrating sedation targeting both optimal P0.1 and appropriate arousal level
* Sedation will be adjusted initially to target light sedation (RASS 0 to -2). * Sedative drugs include IV fentanyl (25-75 mcg/h), midazolam (0.02- 0.1 mg/kg/h), propofol (5-50 mcg/kg/min), dexmedetomidine (0.2-0.7 mcg/kg/h). * Deep sedation and neuromuscular blocking agents are allowed to facilitate mechanical ventilation adjustment in patients with refractory hypoxemia. * Dose of cisatracurium is 0.15-0.2 mg/kg intravenous bolus, then continuous infusion at 5 -20 mg/h. * Then sedation adjustment will be guided by P0.1 measurement. * If P0.1 value of 1.5-3.5 cmH2O is achieved, no further adjustment is required. * If P0.1 value \<1.5, sedation will be reduced. * If P0.1 value \>3.5, sedation will be increased. * If P0.1 value is still \>3.5 with deep sedation, cisatracurium will be allowed and titrated until P0.1 value \<3.5 cmH2O. * The study protocol will be continued for 48 hours or until the patients are considered ready for weaning.
Fentanyl
Continuous intravenous infusion of fentanyl 25-75 micrograms/hour
Midazolam
Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour
Propofol
Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute
Dexmedetomidine
Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour
Cisatracurium
Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour
Locations (1)
Siriraj Hospital
Bangkok, Bangkok, Thailand