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

Launched by SIRIRAJ HOSPITAL · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to sedation for patients who are critically ill and require mechanical ventilation, which is a machine that helps them breathe. The study is comparing a sedation method that focuses on both the patient's breathing needs and their level of wakefulness (called P0.1-guided sedation) to a traditional method that only considers how awake the patient is. The goal is to see if the new method can improve patient comfort and outcomes in the intensive care unit.

To participate in this trial, patients must be at least 18 years old, currently receiving mechanical ventilation for acute respiratory failure, and have been admitted to the medical intensive care unit within the last 72 hours. Certain patients, such as those with specific medical conditions or who have been on mechanical ventilation for too long, will not be eligible. Participants will be randomly assigned to one of the two sedation methods and will be monitored closely throughout the study. This trial is currently recruiting patients, and it aims to provide valuable insights into how to better care for individuals in critical conditions.

Gender

ALL

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