Nurse Education to Reduce Patient-Ventilator Asynchrony in the PICU

NCT ID: NCT07273487

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-10-01

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.

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.

Conditions

Patient-Ventilator Asynchrony; Mechanical Ventilation Complication; Nurse Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nurse Education on Ventilator Waveform and Alarm Management

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse Education on Ventilator Waveform and Alarm Management

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ventilator Waveform Training

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan ağın

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Agin, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Dr. Behcet Uz Children's Hospital

Locations

Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025/977

Identifier Type: -

Identifier Source: org_study_id