Evaluating a new sedation protocol for critically ill patients on mechanical ventilation

The Efficacy of P0.1-guided Sedation Protocol in Critically Ill Patients Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial

This study is testing a new way to provide sedation for critically ill patients on breathing machines to see if it helps them recover better than the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Siriraj Hospital (Academic / other)
• Locations: 1 site (Bangkok, Bangkok)
• Trial ID: NCT06203405 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy of a sedation protocol that targets optimal respiratory drive using P0.1 and arousal level in critically ill patients requiring mechanical ventilation. Patients will be randomized into two groups: one receiving the new sedation approach and the other following a conventional sedation strategy. The study aims to determine if the new protocol improves patient outcomes compared to traditional methods. Monitoring will include arousal levels and respiratory drive throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the medical ICU and require mechanical ventilation due to acute respiratory failure.

Not a fit: Patients who are mechanically ventilated for reasons other than acute respiratory failure or those with certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sedation management and outcomes for patients on mechanical ventilation.

How similar studies have performed: While similar approaches have been explored, this specific protocol targeting both respiratory drive and arousal level is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patients admitted to the medical intensive care unit at Department of Medicine, Siriraj Hospital
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:

1. Patients receiving mechanical ventilation due to indications other than acute respiratory failure, such as postoperative procedures or airway protection in comatose patients
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

Where this trial is running

Bangkok, Bangkok

• Siriraj Hospital — Bangkok, Bangkok, Thailand (Recruiting)

Study contacts

• Principal investigator: Tanuwong Viarasilpa, MD — Division of Critical Care, Department of Medicine, Siriraj Hospital, Mahidol University
• Study coordinator: Natdanai Ketdao, MD

Conditions Respiratory Failure; Critical Illness; Respiratory Distress Syndrome, Adult; Lung Injury; Mechanical Ventilation Complication; acute respiratory failure; sedation; respiratory drive monitoring