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RECRUITING
NCT06203405
NA

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

Sponsor: Siriraj Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

DRUG

Fentanyl

Continuous intravenous infusion of fentanyl 25-75 micrograms/hour

DRUG

Midazolam

Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour

DRUG

Propofol

Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute

DRUG

Dexmedetomidine

Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour

DRUG

Cisatracurium

Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour

Locations (1)

Siriraj Hospital

Bangkok, Bangkok, Thailand