Patient-Ventilator AsynchronyNCT07273487
Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU
A study testing Nurse Education on Ventilator Waveform and Alarm Management in people with Patient-Ventilator Asynchrony and Mechanical Ventilation Complication, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
A prospective cluster-randomized quality improvement trial was conducted to evaluate whether a structured nurse education program on ventilator waveform interpretation and alarm management reduces patient-ventilator asynchrony in the pediatric intensive care unit. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Patient-Ventilator Asynchrony, Mechanical Ventilation Complication, Nurse Education
- What is being tested?
- Nurse Education on Ventilator Waveform and Alarm Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 1 month and 18 years
- Admission to the pediatric intensive care unit (PICU)
- Receiving invasive mechanical ventilation for at least 48 hours (expected or actual)
- Managed with ventilators capable of waveform monitoring and data export
Who cannot join
- Use of continuous neuromuscular blocking agents
- Hemodynamic instability preventing study procedures
- Expected duration of invasive mechanical ventilation < 48 hours
- Lack of informed consent (if applicable per ethics approval)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Behcet Uz Children's Hospital - Pediatric Intensive Care Unit
Izmir
About this study
Official title: Nurse Education on Ventilator Waveform and Alarm Management and Its Impact on Patient-Ventilator Asynchrony and Clinical Outcomes in the Pediatric Intensive Care Unit: A Prospective Cluster-Randomized Controlled Quality Improvement Study
A prospective cluster-randomized quality improvement trial was conducted to evaluate whether a structured nurse education program on ventilator waveform interpretation and alarm management reduces patient-ventilator asynchrony in the pediatric intensive care unit. Two PICU units within the same hospital were randomized to either an Education group or a Control group. Nurses in the Education group received multimodal training, reference cards, and support for real-time waveform review. The primary outcomes were asynchrony index (%) and ventilator alarm frequency (alarms/day). Secondary outcomes included ventilator days, cumulative sedation dose, withdrawal symptoms, nurse accuracy in identifying asynchrony, and nurse workload.
Read the detailed description
Patient-ventilator asynchrony (PVA) is common in mechanically ventilated children and is associated with impaired gas exchange, increased sedation exposure, prolonged mechanical ventilation, and higher morbidity. Recognition and management of asynchrony require real-time waveform interpretation, yet bedside nurses' ability to identify it varies widely.
This prospective cluster-randomized quality improvement study was conducted in two pediatric intensive care units within the same tertiary children's hospital. The two PICUs were randomized 1:1 to either the Education group or the Control group. Children aged 1 month to 18 years who required at least 48 hours of invasive mechanical ventilation were eligible.
In the Education group, bedside nurses participated in a structured, multimodal training program including face-to-face teaching, case-based waveform analysis, alarm management principles, and a mobile platform for sharing ventilator screenshots with an asynchrony review team. Reference pocket cards summarizing common asynchrony patterns and recommended responses were provided. Nurses performed routine waveform checks and communicated suspected asynchrony to the clinical team; ventilator settings were changed only by physicians.
The Control group followed the existing standard of care without nurse-specific training. Asynchrony was quantified using 24-hour waveform recordings exported from the ventilator.
Primary outcomes were asynchrony index (%) and total ventilator alarm frequency (alarms per ventilator day). Secondary outcomes included mechanical ventilation duration, cumulative sedation dose (mg/kg), withdrawal symptoms measured using the WAT-1 score, nurse accuracy before and after training, and nurse workload assessed using the NASA-TLX tool.
- Being tested
- Nurse Education on Ventilator Waveform and Alarm Management
- Medical subject headings
- Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Education on Ventilator Waveform and Alarm ManagementBehavioural
Also called Ventilator Waveform Training
A structured multimodal education program delivered to bedside nurses, including face-to-face teaching, case-based ventilator waveform interpretation, recognition of common patient-ventilator asynchrony patterns, ventilator alarm management principles, reference pocket cards, and real-time waveform sharing with an asynchrony review team. Nurses performed routine waveform checks and reported suspected asynchrony to physicians; ventilator adjustments were performed only by physicians.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Bedside nurses received a structured multimodal education program on ventilator waveform interpretation, recognition of patient-ventilator asynchrony, and ventilator alarm management. The training included face-to-face sessions, case-based waveform discussions, reference pocket cards, and real-time waveform sharing with an asynchrony review team. Nurses conducted routine waveform checks and communicated suspected asynchrony to physicians; ventilator adjustments were performed only by physicians. Receives: Behavioral: Nurse Education on Ventilator Waveform and Alarm Management |
| Control Group | No intervention | Patients received standard care in accordance with existing mechanical ventilation and alarm management protocols. No nurse-specific training on ventilator waveforms or patient-ventilator asynchrony was provided. Asynchrony was assessed using 24-hour ventilator waveform recordings exported for analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony Index (%)
The proportion of asynchronous breaths divided by total breaths, expressed as a percentage. Asynchrony is quantified using 24-hour ventilator waveform recordings.
Measured: Within the first 24 hours of invasive mechanical ventilation
Ventilator Alarm Frequency (alarms/day)
The total number of ventilator alarms per ventilator day, including pressure, volume, and flow-related alarms.
Measured: Within the first 24 hours of invasive mechanical ventilation
Secondary outcomes (4)
Duration of Mechanical Ventilation (days)
Number of days from initiation of invasive mechanical ventilation to successful extubation or transition to noninvasive ventilation.
Measured: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
Cumulative Sedation Dose (mg/kg)
Total cumulative dose of sedative medications administered during mechanical ventilation, normalized to patient weight.
Measured: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
Nurse Accuracy in Identifying Asynchrony (%)
Proportion of correctly identified asynchrony patterns on pre-training and post-training waveform tests.
Measured: Within the first 24 hours of invasive mechanical ventilation
Withdrawal Severity (WAT-1 Score)
Maximum Withdrawal Assessment Tool-1 (WAT-1) score recorded during mechanical ventilation and weaning.
Measured: Up to 48 hours after extubation following a period of mechanical ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-Ventilator AsynchronyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two pediatric intensive care units were randomized as clusters to Education vs Control groups.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
- Investigators
- Hasan Agin, Prof.Dr., Principal investigator, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273487
- Sponsor's protocol ID
- 2025/977
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Education on Ventilator Waveform and Alarm Management and Its Impact on Patient-Ventilator Asynchrony and Clinical Outcomes in the Pediatric Intensive Care Unit: A Prospective Cluster-Randomized Controlled Quality Improvement Study
- ClinicalTrials.gov ID
- NCT07273487
- Acronym / sponsor ID
- 2025/977
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 9 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.
A prospective cluster-randomized quality improvement trial was conducted to evaluate whether a structured nurse education program on ventilator waveform interpretation and alarm management reduces patient-ventilator asynchrony in the pediatric intensive care unit. Two PICU units within the same hospital were randomized to either an Education group or a Control group. Nurses in the Education group received multimodal training, reference cards, and support for real-time waveform review. The primary outcomes were asynchrony index (%) and ventilator alarm frequency (alarms/day). Secondary outcomes included ventilator days, cumulative sedation dose, withdrawal symptoms, nurse accuracy in identifying asynchrony, and nurse workload.
Detailed description
Patient-ventilator asynchrony (PVA) is common in mechanically ventilated children and is associated with impaired gas exchange, increased sedation exposure, prolonged mechanical ventilation, and higher morbidity. Recognition and management of asynchrony require real-time waveform interpretation, yet bedside nurses' ability to identify it varies widely.
This prospective cluster-randomized quality improvement study was conducted in two pediatric intensive care units within the same tertiary children's hospital. The two PICUs were randomized 1:1 to either the Education group or the Control group. Children aged 1 month to 18 years who required at least 48 hours of invasive mechanical ventilation were eligible.
In the Education group, bedside nurses participated in a structured, multimodal training program including face-to-face teaching, case-based waveform analysis, alarm management principles, and a mobile platform for sharing ventilator screenshots with an asynchrony review team. Reference pocket cards summarizing common asynchrony patterns and recommended responses were provided. Nurses performed routine waveform checks and communicated suspected asynchrony to the clinical team; ventilator settings were changed only by physicians.
The Control group followed the existing standard of care without nurse-specific training. Asynchrony was quantified using 24-hour waveform recordings exported from the ventilator.
Primary outcomes were asynchrony index (%) and total ventilator alarm frequency (alarms per ventilator day). Secondary outcomes included mechanical ventilation duration, cumulative sedation dose (mg/kg), withdrawal symptoms measured using the WAT-1 score, nurse accuracy before and after training, and nurse workload assessed using the NASA-TLX tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two pediatric intensive care units were randomized as clusters to Education vs Control groups.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Behavioral: Nurse Education on Ventilator Waveform and Alarm ManagementBedside nurses received a structured multimodal education program on ventilator waveform interpretation, recognition of patient-ventilator asynchrony, and ventilator alarm management. The training included face-to-face sessions, case-based waveform discussions, reference pocket cards, and real-time waveform sharing with an asynchrony review team. Nurses conducted routine waveform checks and communicated suspected asynchrony to physicians; ventilator adjustments were performed only by physicians. |
| Control Group | No intervention | –Patients received standard care in accordance with existing mechanical ventilation and alarm management protocols. No nurse-specific training on ventilator waveforms or patient-ventilator asynchrony was provided. Asynchrony was assessed using 24-hour ventilator waveform recordings exported for analysis. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 1 month and 18 years
- Admission to the pediatric intensive care unit (PICU)
- Receiving invasive mechanical ventilation for at least 48 hours (expected or actual)
- Managed with ventilators capable of waveform monitoring and data export
Key exclusion criteria (4 listed)
- Use of continuous neuromuscular blocking agents
- Hemodynamic instability preventing study procedures
- Expected duration of invasive mechanical ventilation < 48 hours
- Lack of informed consent (if applicable per ethics approval)
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 |
|---|---|---|
| Nurse Education on Ventilator Waveform and Alarm ManagementAlso: Ventilator Waveform TrainingA structured multimodal education program delivered to bedside nurses, including face-to-face teaching, case-based ventilator waveform interpretation, recognition of common patient-ventilator asynchrony patterns, ventilator alarm management principles, reference pocket cards, and real-time waveform sharing with an asynchrony review team. Nurses performed routine waveform checks and reported suspected asynchrony to physicians; ventilator adjustments were performed only by physicians. | Behavioural | Education Group |
Primary outcome
Asynchrony Index (%)
Time frame: Within the first 24 hours of invasive mechanical ventilation
The proportion of asynchronous breaths divided by total breaths, expressed as a percentage. Asynchrony is quantified using 24-hour ventilator waveform recordings.
Ventilator Alarm Frequency (alarms/day)
Time frame: Within the first 24 hours of invasive mechanical ventilation
The total number of ventilator alarms per ventilator day, including pressure, volume, and flow-related alarms.
4 secondary outcomes
Duration of Mechanical Ventilation (days)
Time frame: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
Cumulative Sedation Dose (mg/kg)
Time frame: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
Nurse Accuracy in Identifying Asynchrony (%)
Time frame: Within the first 24 hours of invasive mechanical ventilation
Withdrawal Severity (WAT-1 Score)
Time frame: Up to 48 hours after extubation following a period of mechanical ventilation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data.
Related trials for Patient-Ventilator Asynchrony
Not yet recruitingObservational study
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
RecruitingObservational study
Analysis and Evaluation of Asynchronies Between NIV Patients and Their Prisma VENT or LUISA Ventilator
Patient Ventilator Interactions
RecruitingObservational study
Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care
Mechanical Ventilation, Patient-Ventilator Asynchrony
Enrolling by invitationObservational study
Standardising Terminology, Classification, Diagnostic Recognition and Reporting of Patient-ventilator Interactions: Protocol for an International Delphi Consensus Study
Patient-Ventilator Interaction, Asynchrony, Patient-Ventilator
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. This study is not recruiting at the moment.
Hasan Agin, Prof.Dr. principal investigator
Dr. Behcet Uz Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Education on Ventilator Waveform and Alarm Management in people with Patient-Ventilator Asynchrony and Mechanical Ventilation Complication, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asynchrony Index (%) (time frame: Within the first 24 hours of invasive mechanical ventilation). The study lists 2 primary outcomes in all. 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 9 Dec 2025.