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

NARecruitingINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

December 22, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
Respiratory FailureCritical IllnessRespiratory Distress Syndrome, AdultLung InjuryMechanical Ventilation Complication
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

Trial Locations (1)

10700

RECRUITING

Siriraj Hospital, Bangkok

All Listed Sponsors
lead

Siriraj Hospital

OTHER