- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273487
Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Izmir, Turkey (Türkiye)
- Behcet Uz Children's Hospital - Pediatric Intensive Care Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education Group
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.
|
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.
Other Names:
|
|
No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asynchrony Index (%)
Time Frame: Within the first 24 hours of invasive mechanical ventilation
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The proportion of asynchronous breaths divided by total breaths, expressed as a percentage.
Asynchrony is quantified using 24-hour ventilator waveform recordings.
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Within the first 24 hours of invasive mechanical ventilation
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Ventilator Alarm Frequency (alarms/day)
Time Frame: Within the first 24 hours of invasive mechanical ventilation
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The total number of ventilator alarms per ventilator day, including pressure, volume, and flow-related alarms.
|
Within the first 24 hours of invasive mechanical ventilation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of Mechanical Ventilation (days)
Time Frame: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
|
Number of days from initiation of invasive mechanical ventilation to successful extubation or transition to noninvasive ventilation.
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Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
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Cumulative Sedation Dose (mg/kg)
Time Frame: Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
|
Total cumulative dose of sedative medications administered during mechanical ventilation, normalized to patient weight.
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Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.
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Nurse Accuracy in Identifying Asynchrony (%)
Time Frame: Within the first 24 hours of invasive mechanical ventilation
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Proportion of correctly identified asynchrony patterns on pre-training and post-training waveform tests.
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Within the first 24 hours of invasive mechanical ventilation
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Withdrawal Severity (WAT-1 Score)
Time Frame: Up to 48 hours after extubation following a period of mechanical ventilation.
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Maximum Withdrawal Assessment Tool-1 (WAT-1) score recorded during mechanical ventilation and weaning.
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Up to 48 hours after extubation following a period of mechanical ventilation.
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Collaborators and Investigators
Investigators
- Principal Investigator: Hasan Agin, Prof.Dr., Dr. Behcet Uz Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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