Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU

NCT07273487 | Completed

• 1 other identifier: 2025/977
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Patient-Ventilator Asynchrony; Mechanical Ventilation Complication; Nurse Education

Outcome Measures

Primary Outcomes (2)

• Asynchrony Index (%)

  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)

  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 Outcomes (4)

• Duration of Mechanical Ventilation (days)

  Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.

• Cumulative Sedation Dose (mg/kg)

  Up to 28 days or until discontinuation of invasive mechanical ventilation, whichever comes first.

• Nurse Accuracy in Identifying Asynchrony (%)

  Within the first 24 hours of invasive mechanical ventilation

• Withdrawal Severity (WAT-1 Score)

  Up to 48 hours after extubation following a period of mechanical ventilation.

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Ventilator Waveform Training

Education Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasan Agin, Prof.Dr.

  Dr. Behcet Uz Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: Two pediatric intensive care units were randomized as clusters to Education vs Control groups.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 9, 2025
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)