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

NCT07291622 | Not Yet Recruiting

• 1 other identifier: IR.SBMU.RETECH.REC.1404.593
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Non-Invasive Ventilation; Patient-Ventilator Synchrony; Intensive Care Unit (ICU); Anxiety and Depression; Randomized Clinical Trial; Patient Comfort

Outcome Measures

Primary Outcomes (1)

• NIV Usage

  Adherence data, including daily NIV usage, will be retrieved from the NIV machine. Adherence will be defined as more than 4 hours of nighttime use for more than 70% of days until study completion or a mean daily use of more than 5 hours.

  Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

Secondary Outcomes (3)

• Anxiety and Depression

  Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

• Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events

  Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

• Comfort

  Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

Study Arms (2)

SYNC-NIV

EXPERIMENTAL

The intervention will consist of a structured two-session synchrony-optimized NIV education program designed to improve patient-ventilator interaction and reduce NIV-related complications. In the first 20-40-minute session, patients will be taught the ventilator's inspiratory and expiratory cycles and will practice synchronizing their breathing with the device through guided diaphragmatic exercises and real-time feedback until they demonstrate stable synchrony. The second 45-60-minute session, delivered 18-24 hours later, will provide supplementary training on proper mask selection and fixation, prevention of common NIV complications, leak reduction techniques, equipment maintenance, advanced breathing exercises, and basic ventilator monitoring and alarm management. An educational booklet summarizing all essential topics will be provided to support ongoing adherence and self-management.

Other: SYNC-NIV

Control Group

NO INTERVENTION

Standard care will include regular education on the ICU environment, basic intensive care processes, the use of monitoring devices, ICU rules, effective communication with critically ill patients, and basic principles of patient care.

Interventions

SYNC-NIV OTHER

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.

SYNC-NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

MeSH Terms

Conditions

Patient-Ventilator Asynchrony; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: December 19, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 10, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12