Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYNC-NIV.
- Who it may be relevant to
- Registry conditions: Ventilator Associated Events, Asynchrony, Patient-Ventilator, Intensive Care (ICU), Noninvasive Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of a Synchrony-Optimized Non-Invasive Ventilation Education Program on Intensive Care Unit Patients' Outcomes: A Randomized Clinical Trial Protocol
Overview
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.
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, l
Primary outcome measures
- NIV Usage [Time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion]
Secondary outcome measures (3)
- Anxiety and Depression [Time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion]
- Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events [Time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion]
- Comfort [Time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion]
Eligibility criteria
Inclusion criteria
- Adult patients over 18 years of age
- Admitted to the ICU for at least 24 hours
- Anticipated to be hospitalized for more than one week
- Receiving NIV treatment for any underlying condition
- Capable of learning
- Proficient in the Persian language
Exclusion criteria
- Patients with Richmond Agitation-Sedation Scale (RASS) scores of +4 or -5
- Patients with cognitive disorders
- Patients with neurological disorders
- Patients with anxiety disorders
- Patients whose condition deteriorates, making continued cooperation impossible
- Patients unable to participate in educational sessions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07291622 · IR.SBMU.RETECH.REC.1404.593