Status:
RECRUITING
The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Lead Sponsor:
Siriraj Hospital
Conditions:
Respiratory Failure
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 le...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06203405
Start Date
December 22 2023
End Date
June 30 2026
Last Update
May 22 2025
Active Locations (1)
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1
Siriraj Hospital
Bangkok, Bangkok, Thailand, 10700