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Tests treatment safety and results for Respiratory Failure
Official title The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06203405
What this study is testing
What is Fentanyl?
Fentanyl is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for respiratory failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway...
- 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...
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Bangkok, Thailand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.