NCT07291622

Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients

Effect of a Synchrony-Optimized Non-Invasive Ventilation Education Program on Intensive Care Unit Patients' Outcomes: A Randomized Clinical Trial Protocol

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to find out whether a synchrony-optimized education program for non-invasive ventilation (NIV) can help ICU patients use their ventilator more effectively and improve their comfort, symptoms, and psychological well-being. Researchers want to answer these main questions: Can a structured two-session NIV education program help patients use their ventilator more regularly and for longer periods? Does this type of training reduce anxiety, depression, and respiratory symptoms? Can synchrony training improve patients' comfort and reduce NIV-related problems such as mask leaks or sleep disturbances? Is this program more effective than the routine ICU education normally provided? What Will Happen in the Study Adults (18+) who are receiving NIV in the ICU will participate in this study. Participants will be randomly assigned to one of two groups: Intervention Group: Will receive the SYNC-NIV education program, consisting of: One hands-on session (20-40 minutes) teaching patients how to synchronize their breathing with the ventilator One supplementary session (45-60 minutes) covering mask management, preventing complications, reducing leaks, breathing exercises, equipment care, and alarm handling An educational booklet for continued support Control Group: Will receive the standard ICU education normally provided about the ICU environment, general care, communication, and monitoring. All participants will be evaluated at three times: before the intervention, the day after the program ends, and one week later.

Conditions

• Ventilator Associated Events
• Asynchrony, Patient-Ventilator
• Intensive Care (ICU)
• Noninvasive Ventilation

Interventions

Type	Name	Description
OTHER	SYNC-NIV	The intervention will include two educational sessions to improve patient-ventilator synchrony and NIV management. The first session will teach patients about the ventilator's breathing cycles and train them to coordinate their breathing using visual aids and hands-on practice with real-time feedback. Competency will be assessed by their ability to maintain synchrony with minimal mask leak. The second session, held 18-24 hours later, will cover mask fitting, prevention of common complications, leak reduction, equipment care, advanced breathing exercises, and basic ventilator alarm management. Communication and relaxation techniques will also be taught, and patients will receive a booklet summarizing the key information.

Timeline

• Start date: 2025-12-19
• Primary completion: 2025-12-30
• Completion: 2026-01-10
• First posted: 2025-12-18
• Last updated: 2025-12-24