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临床试验/NCT04112459
NCT04112459Unknown不适用

Prolonged Mechanical Ventilation in Paediatric Intensive Care : An International Cross-Sectional Prevalence Study

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2019年9月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
6,000
试验地点
1
主要终点
Prevalence of PMV

研究概览

简要总结

Scientific advances, population growth, lower mortality, and increasing complexity of diseases have boosted up the number of patients requiring prolonged breathing assistance with mechanical ventilators in the pediatric intensive care units (PICU) in many parts of the developed world. Previous studies also suggest that there is a small group of children who actually need such a high level of support for extended periods of time, utilizing a lot of human and technical resources. We defined children with prolonged mechanical ventilation (PMV) if they required supports with a breathing machine for more than 14 days. We propose an international point prevalence study of children requiring PMV in PICU. We will conduct the study in multiple centers in several different regions, including North and South America, Europe, and Asian countries, with a strong relationship with local physician colleagues. Practice for patients requiring PMV will be examined including the type and size of local PICU, admission and discharge policies, and patient and treatment modalities administered to such patients, types of professionals looking after patients in PMV, types of health care. We anticipate a high variability in practices suggesting a need to further standardize the management of PMV.. Specifically, as an immediate consequence, by comparing and understanding the differences in patient demographics, practice details among PICUs in regards to the background factors of local PICUs and their patients, practitioners will share their way of dealing with such patients. In that way, this study will support the need to generate guidelines and lead to patient care improvement in PICUs.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients who are ventilated >14 consecutive days (after 37 weeks postmenstrual post-conception age)*
  • including for more than 6 hours per day including on InMV and NIV duration
  • patient who have had and short interruptions (<48hours) of ventilation during the weaning process as the same episode of ventilation can be included.
  • InMV can be administered through an endotracheal tube or a tracheostomy tube.
  • NIV can be managed through a nasal, full-face, total facial mask, or helmet.
  • Patient on HFNC will be included as on respiratory support if they have a proper or a nasal cannula (that allows >=1 liters/kg/min (LPM) and >4LPM).
  • We define nasal oxygen supply <1 L/kg/min as non-NIV practice.

排除标准

  • Age >18 years
  • Already included in this study
  • No consent if required
  • Brain death
  • Premature children not yet at 37 weeks gestational age.

结局指标

主要结局

Prevalence of PMV

时间窗: eight times during two-year study period

number of patients meet PMV criteria devided by the number of patients admitted in PICUs on the specific data collection date and time.

次要结局

  • Patient and treatment demographics(eight times during two-year study period)
  • Outcomes at 90days follow-up(90 days from the initial data collection)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atsushi Kawaguchi

Postdoctoral Scholar

St. Justine's Hospital

研究点 (1)

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