NCT06242236

Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this research is to utilize respiratory effort parameters as a tool to assist in adjusting sedative drug levels for patients undergoing mechanical ventilation in the intensive care unit, in comparison to the conventional usual care approach.

Detailed description

The research investigators conduct daily screening for new participation in the intensive care unit and semi-intensive care unit, selecting individuals based on inclusion and exclusion criteria. In cases where patients require sedative drugs before the research investigators assessment, such as when patients are agitated or have difficulty asynchrony, standard sedative dosages are allowed in emergency rooms and the intensive care unit. * Informed consent for participation in the research is obtained from direct relatives of participants, accompanied by an explanation of the research procedures, methods, and potential complications. Relatives are required to sign the consent form as the primary decision-makers, considering the participants may be in an altered state of awareness and decision-making capacity. * Participants meeting the inclusion and exclusion criteria are registered for the research project and assigned a participant identification code. They are divided into two groups: one receiving the intervention involving the measurement of respiratory effort using P0.1 and Pocc then calculating to dynamic transpulmonary pressure swing (Predicted ΔPL) to adjust sedative drugs, and the other, serving as the control group, receives usual care adjustments made by the ward physicians' decision. The randomization process is facilitated by a third party. The randomization involves creating equally distributed tokens for both groups (1:1 ratio), with the total number (n) representing the population to be included in the study. These tokens are placed in a random box for the randomization process. The basic information of research participants, laboratory, and mechanical ventilator parameters will be collected.

Conditions

• ARDS
• Respiratory Effort
• Mechanical Ventilation Complication
• Sedation

Interventions

Type	Name	Description
OTHER	The respiratory effort parameters guide sedative dosage.	The intervention involves the measurement of respiratory effort using P0.1 and Pocc then calculating to dynamic transpulmonary pressure swing (Predicted ΔPL) to adjust sedative drug dosage.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-31
• Completion: 2025-06-30
• First posted: 2024-02-05
• Last updated: 2025-07-22

Locations

1 site across 1 country: Thailand