NCT06203405

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Siriraj Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objective: to assess the efficacy of sedation protocol targeting optimal respiratory drive using P0.1 and RASS score compared with conventional sedation strategy (targeting RASS score alone) in patients requiring mechanical ventilation in the medical intensive care unit The main questions it aims to answer are: • Will titration of sedation targeting optimal respiratory drive assessed by P0.1 and arousal level improve outcomes in patients requiring mechanical ventilation in the medical ICU? Study protocol Mechanically ventilated patients admitted to the medical ICU will be screened daily by the investigators. If the patients meet the eligibility criteria, they will be informed about the study protocol and potential risks and undergo informed consent. Then patients will be randomized in a 1:1 ratio and allocated to each study group (intervention and control group). * After allocation, patients will be monitored for arousal level using RASS score and respiratory drive by P0.1 measured automatically from mechanical ventilators during the study period. * Sedation and neuromuscular blocking agents used will be adjusted according to the group to which patients are allocated. * Intervention group: Adjustment of sedation and neuromuscular blocking agents to achieve the target of light sedation (RASS 0 to -2) and optimal P0.1 (1.5 to 3.5 cmH2O) for 48 hours * Control group: Adjustment of sedation to achieve the target of light sedation (RASS 0 to -2) alone for 48 hours Researchers will compare the outcomes (rate of successful extubation, ICU and hospital mortality, ICU and hospital length of stay, duration of mechanical ventilation, amount and duration of sedation used during the study period) between the above sedation protocol (interventional group) and conventional sedation strategy (control group)

Conditions

• Respiratory Failure
• Critical Illness
• Respiratory Distress Syndrome, Adult
• Lung Injury
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-22
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2024-01-12
• Last updated: 2025-05-22

Locations

1 site across 1 country: Thailand