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临床试验/NCT07273487
NCT07273487已完成不适用

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

Dr. Behcet Uz Children's Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Asynchrony Index (%)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Asynchrony Index (%)

时间窗: 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.

Ventilator Alarm Frequency (alarms/day)

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan ağın

Prof.Dr

Dr. Behcet Uz Children's Hospital

研究点 (1)

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