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Completed

NCT Number: NCT07273487

Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nurse Education on Ventilator Waveform and Alarm Management

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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