The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Siriraj Hospital
214 participants
Dec 22, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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)
Exclusion Criteria12
- 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
- Patients with severe metabolic acidosis (arterial pH <7.2) who do not have a plan for renal replacement therapy
- Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases
- Post-cardiac arrest patients
- Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C
- Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs
- Pregnancy
- Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
- Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment
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Interventions
* 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.
Continuous intravenous infusion of fentanyl 25-75 micrograms/hour
Continuous intravenous infusion of midazolam 0.02 - 0.1 milligrams/kilogram/hour
Continuous intravenous infusion of propofol 5 - 50 micrograms/kilogram/minute
Continuous intravenous infusion of dexmedetomidine 0.2 - 0.7 micrograms/kilogram/hour
Continuous intravenous infusion of cisatracurium 5 - 20 milligrams/hour
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06203405