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临床试验/NCT01598246
NCT01598246已完成不适用

Prospective Observational Study on Factors Influencing Re-Intubation Following a Planned Extubation (RIPE) in a Pediatric Intensive Care Unit: Identifying Targets for a Quality Improvement Initiative

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1

研究概览

简要总结

This is a prospective chart review of all extubations in the pediatric intensive care unit. Over a one year period all extubations in the unit are to be recorded on a designated form and standard variables charted and compared. All data will be collected from the chart, retrospectively after the extubation event. Patients who fail extubation will be compared to those who succeed. We aim to identify factors which contribute to extubation failures in the unit, to come up with a unit specific extubation policy

详细描述

Description of project- This is a prospective chart review to identify factors influencing a successful extubation event.

Hypothesis- Successful extubation in a pediatric intensive care unit is dependent on variables, which can be identified and the chances of success predicted. A clinical practice based upon such a prediction model, will improve the quality of care provided to the patients.

Type- Prospective chart review .

Procedure- Over 1 year period, all planned extubations in the intensive care unit to be recorded on a designated form and standard variables charted. All extubation decisions are to be made by the covering attending physician and at no time, the study protocol will affect/influence or alter the standard patient care. All data will be collected retrospectively after the extubation event. All included patients will be assigned a unique identification number (UID) by the investigator, who will secure the patient identifiers in an encrypted electronic file. Extubation failure will be defined as reintubation within 72 hours of a planned extubation and will be further classified as early (<12 hours) and late (12-72 hours) extubation failure. The cause of extubation failure will be recorded (as identified by the attending physician on service, who is not involved in the study).

Data collection and statistical analysis- The data will be collected on a standard form. The data collected will be periodically logged in an electronic data base and analyzed. Investigators will perform an interim analysis at the end of 6 months and a final analysis of the data at the end of 1 year period. Since this is an observational study, all the extubations in the time period, will be included. Based on 2010 data collected, for monitoring unplanned extubations (300 extubations) and considering recent expansion in their unit, investigators expect about 500 extubations in the time period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • All planned extubations in pediatric Intensive care unit

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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