The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
NCT ID: NCT06203405
Last Updated: 2025-05-22
Study Results
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Basic Information
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RECRUITING
NA
214 participants
INTERVENTIONAL
2023-12-22
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Titrating sedation targeting both optimal P0.1 and appropriate arousal level
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) and optimal respiratory drive measured by P0.1 of 1.5 - 3.5 cmH2O
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
Titrating sedation targeting appropriate arousal level alone
• Sedative drug adjustment to achieve the target of light sedation (RASS 0 to -2) according to the standard clinical practice guidelines for managing pain and agitation for patients receiving mechanical ventilation in the ICU.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years old
3. Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)
Exclusion Criteria
2. Patients receiving mechanical ventilation for \>72 hours before enrollment
3. Patients receiving neuromuscular blocking agents prior to randomization
4. Patients with impaired secretion clearance or upper airway obstruction anticipating a tracheostomy
5. Patients with severe metabolic acidosis (arterial pH \<7.2) who do not have a plan for renal replacement therapy
6. Patients intubated for neurological conditions, including intracranial hypertension, intracranial hemorrhage, large cerebral infarction, status epilepticus, or neuromuscular diseases
7. Post-cardiac arrest patients
8. Patients with severe liver dysfunction, including acute fulminant liver failure or cirrhosis with the Child-Pugh score B or C
9. Patients who have a previous allergy to any of the opioid, sedation, or neuromuscular blocking drugs
10. Pregnancy
11. Patients with do-not-resuscitate (DNR) orders or decisions to withhold life-sustaining treatments
12. Patients who refuse to participate in the study or cannot identify legally authorized representatives (LAR) within 24 hours after enrollment
18 Years
ALL
No
Sponsors
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Siriraj Hospital
OTHER
Responsible Party
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Natdanai Ketdao
Principal Investigator
Principal Investigators
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Tanuwong Viarasilpa, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
Natdanai Ketdao, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
Locations
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Siriraj Hospital
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SI915/2023
Identifier Type: -
Identifier Source: org_study_id
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