Actively Recruiting
The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Led by Siriraj Hospital · Updated on 2025-05-22
214
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital
- Age 18 years or older
- Receiving mechanical ventilation due to acute respiratory failure within 72 hours before enrollment (including patients receiving mechanical ventilation before ICU admission)
You will not qualify if you...
- Receiving mechanical ventilation for reasons other than acute respiratory failure, such as postoperative care or airway protection in coma
- Receiving mechanical ventilation for more than 72 hours before enrollment
- Receiving neuromuscular blocking agents before randomization
- Having impaired secretion clearance or upper airway obstruction expecting tracheostomy
- Having severe metabolic acidosis with arterial pH less than 7.2 without plans for renal replacement therapy
- Intubated for neurological conditions like intracranial hypertension, hemorrhage, large stroke, status epilepticus, or neuromuscular diseases
- Post-cardiac arrest patients
- Severe liver dysfunction including acute liver failure or cirrhosis with Child-Pugh score B or C
- Previous allergy to opioids, sedation, or neuromuscular blocking drugs
- Pregnancy
- Having do-not-resuscitate orders or decision to withhold life-sustaining treatment
- Refusal to participate or inability to identify legally authorized representatives within 24 hours after enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Siriraj Hospital
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
Research Team
N
Natdanai Ketdao, MD
CONTACT
T
Tanuwong Viarasilpa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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