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

NCT07291622 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-12-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2025-12-30
Completion
2026-01-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291622 on ClinicalTrials.gov