A Multicentered Study on Efficiency of Noninvasive Ventilation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- To determine the incidence of NIV failure as re-intubation within 48 hours.
研究概览
简要总结
Noninvasive ventilation (NIV) is an alternative form of ventilatory support in critical care encompassing different modes of ventilation such as continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and high flow nasal cannula ventilation. Although numerous studies on adults exit in literature, the aspects of this ventilatory support is limited in pediatric age groups. Early recognition of respiratory failure and initiation of NIV in a pediatric patient would positively affect prognosis by avoiding certain complications of endotracheal intubation and mechanical ventilation and adds certain advantages. Decreasing re-intubation rates for the ones who are extubated but necessitating further oxygen support is another advantage of NIV. Although numerous studies on adults exit in literature, the aspects of this ventilatory support is limited in pediatric age groups. Besides, success as well as failure and complication rates in pediatric age groups vary extensively. This multi-centered, prospective cohort study is planned to observe the epidemiologic perspectives of study group within underlying problems, success rates between different age groups, complication and re-intubation rates and finally its' effect on prognosis and long term survival in a year period. Hence we believe results of this study would allow us to improve our knowledge on using this technique, applying different modes and parameters appropriately and design criteria to guide clinician in deciding which group of patients would benefit from NIV techniques.
详细描述
Total of 9 pediatric critical care centers all across the country will collaborate at this study:
- Akdeniz University Faculty of Medicine, Pediatric Critical Care Division
- Cukurova University Faculty of Medicine, Pediatric Critical Care Division
- Ege University Faculty of Medicine, Pediatric Critical Care Division
- Ankara University Faculty of Medicine, Pediatric Critical Care Division
- Ondokuz Mayis University Faculty of Medicine, Pediatric Critical Care Division
- Erciyes University Faculty of Medicine, Pediatric Critical Care Division
- Koc University Faculty of Medicine, Pediatric Critical Care Division
- Dokuz Eylül University Faculty of Medicine, Pediatric Critical Care Division
- Izmir Katip Celebi University Faculty of Medicine, Pediatric Critical Care Division Since nature of this study is an observational cohort, all noninvasively ventilated children from one month to eighteen years will be enrolled in this study. A three-page questionnaire is designed to collect data. The first page includes information on epidemiological data, underlying disease in terms of both acute and chronicle problems resulting in respiratory problems; the second page includes a multi-colon table to record vital signs (heart and respiratory rate, systemic and diastolic blood pressure), PRISM-III and Pediatric logistic organ dysfunction (PELOD) scores, Glasgow coma scale, blood gas values, ventilation parameters, necessity of sedation (if so, drugs used for sedation) and finally comfort pain scores. Data will be collected immediately prior to commencing NIV, the first, second and sixth hours; if NIV support continues over 24 hours, then daily data will be obtained up to five days. Last questionnaire page consists of data for clinical outcome, reason of NIV failure, necessity of re-intubation and if so timing of re-intubation.
Primary outcome of this study is to observe success rates in decreasing necessity of mechanical ventilation or re-intubation. Successfully managed children will also be evaluated for age groups, underlying disease as well as modes of delivery and ventilation parameters to define thresholds on decision of NIV success or failure. Secondary outcome is to evaluate the NIV failure in terms of pediatric age groups, underlying disease, rates of NIV-related complications. If a respiratory failure occurs, modes of delivery and ventilation parameters, usage of different masks, timing of failure decision according to patients' clinical data will be explored from collected data.
Each center will fill in the questionnaire according to patient data and every two months period data will be collected from collaborators. After one year period, statistical evaluation will be investigated by the principle investigators.
Below participants may observe the questionnaire form:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To determine the incidence of NIV failure as re-intubation within 48 hours.
时间窗: 1 year
NIV failure is also determined as re-intubation within 48 hours for those who were previously intubated and received noninvasive ventilation following extubation. Second primary outcome will be evaluated by Form - I question-6 and Form - III question-1.
To determine the incidence of NIV failure in children requiring invasive mechanical ventilation
时间窗: one year
NIV failure is defined as necessity of endotracheal intubation due to respiratory insufficiency within 48 hours in children receiving noninvasive ventilation in pediatric critical care units. Statistical analysis will be performed according to answers to form-I question-6 and form-III question-1 in the questionnaire.
次要结局
- To explore complication rates directly related to noninvasive ventilation.(one year)
- To explore prognosis of patients receiving noninvasive ventilation(one year)
- To observe NIV success for those who receive noninvasive ventilation over 48 hours(one year)
- To determine the reasons resulting in NIV failure in children enrolled in the study(one year)
研究者
Oguz Dursun
MD, Associate Professor
Akdeniz University