Ventilator Associated EventsNCT07291622
Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients
A study testing SYNC-NIV in people with Ventilator Associated Events and Asynchrony, Patient-Ventilator, run by Shahid Beheshti University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Events, Asynchrony, Patient-Ventilator, Intensive Care (ICU)
- What is being tested?
- SYNC-NIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effect of a Synchrony-Optimized Non-Invasive Ventilation Education Program on Intensive Care Unit Patients' Outcomes: A Randomized Clinical Trial Protocol
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:
Read more
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
- Being tested
- SYNC-NIV
- Keywords
- Non-Invasive Ventilation, Patient-Ventilator Synchrony, Intensive Care Unit (ICU), Anxiety and Depression, Randomized Clinical Trial, Patient Comfort
- Medical subject headings
- Patient-Ventilator Asynchrony, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNC-NIVOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
Secondary outcomes (3)
Anxiety and Depression
Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report instrument divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each comprising seven items. Participants will rate each item on a 4-point scale (0-3), yielding subscale scores ranging from 0 to 21. Scores for both subscales will be interpreted as follows: 0-7 indicating no symptoms, 8-10 mild, 11-14 moderate, and 15-21 severe. The internal consistency of the anxiety subscale (HADS-A) and depression subscale (HADS-D) will have been demonstrated with Cronbach's alpha coefficients of 0.820 and 0.807, respectively. The Persian version of the HADS will have shown good reliability and validity in clinical populations. Montazeri et al. (2003) will have found it acceptable by 99% of patients, with Cronbach's alpha of 0.78 for anxiety and 0.86 for depression subscales.
Measured: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events
Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events The S3-NIV Questionnaire will be a self-administered tool that includes 11 questions, all scored by patients on a 5-point Likert scale that ranges from 0 to 4 (0 = always true; 1 = mostly true; 2 = sometimes true; 3 = mostly untrue; 4 = completely untrue), based on their experiences over the previous four weeks. To calculate the overall score, the average of all completed items will be multiplied by 2.5. A score of zero will reflect the highest degree of disease impact, whereas a score of ten will reflect the lowest. Two subscale scores may also be derived: the "Respiratory Symptoms" sub score will be computed by averaging responses to items 1, 4, 5, 6, and 7 and multiplying by 2.5, while the "Sleep \& Side Effects" sub score will be based on the average of items 2, 3, 8, 9, 10, and 11, also multiplied by 2.5.
Measured: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
Comfort
To evaluate participants' comfort levels, the Visual Analog Scale (VAS) will be employed. The VAS will be a widely used, reliable, and sensitive instrument for assessing subjective experiences such as comfort (6). It typically will consist of a 10-centimeter horizontal line anchored by two extremes, for example, "no discomfort" on the left end (score 0) and "worst possible discomfort" on the right end (score 10). Participants will mark a point along the line that best represents their perceived level of comfort. The simplicity, sensitivity, and ease of administration of the VAS will make it a preferred tool in both clinical and research settings for quantifying subjective states.
Measured: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start19 Dec 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sogand Sarmadi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291622
- Sponsor's protocol ID
- IR.SBMU.RETECH.REC.1404.593
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Synchrony-Optimized Non-Invasive Ventilation Education Program on Intensive Care Unit Patients' Outcomes: A Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07291622
- Acronym / sponsor ID
- IR.SBMU.RETECH.REC.1404.593
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 19 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNC-NIV | Experimental | Other: SYNC-NIVThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNC-NIVThe 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. | Other | SYNC-NIV |
Primary outcome
NIV Usage
Time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SYNC-NIV in people with Ventilator Associated Events and Asynchrony, Patient-Ventilator, run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIV Usage (time frame: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.