Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU

November 26, 2025 updated by: Hasan ağın, Dr. Behcet Uz Children's Hospital

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.

Study Overview

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

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Izmir, Turkey (Türkiye)
        • Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Ventilator Waveform Training
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.

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
The proportion of asynchronous breaths divided by total breaths, expressed as a percentage. Asynchrony is quantified using 24-hour ventilator waveform recordings.
Within the first 24 hours of invasive mechanical ventilation
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.
Within the first 24 hours of invasive mechanical ventilation

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.
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.
Total cumulative dose of sedative medications administered during mechanical ventilation, normalized to patient weight.
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
Proportion of correctly identified asynchrony patterns on pre-training and post-training waveform tests.
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.
Maximum Withdrawal Assessment Tool-1 (WAT-1) score recorded during mechanical ventilation and weaning.
Up to 48 hours after extubation following a period of mechanical ventilation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hasan Agin, Prof.Dr., Dr. Behcet Uz Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study does not plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Mechanical Ventilation Complication

Clinical Trials on Nurse Education on Ventilator Waveform and Alarm Management

Subscribe