Identifying and Understanding Risk Factors for Instability and Adverse Events Associated With Chest Physiotherapy in Ventilated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Oxygenation
研究概览
简要总结
Paediatric intensive care units support the complex medical needs of children with life threatening conditions. There are 20000 admissions annually within the United Kingdom and 65% require life support through a breathing machine. Chest physiotherapy is considered part of routine care for these patients. There is a small amount of evidence providing support for the effectiveness of chest physiotherapy however it has been associated with instability and adverse events. At present the risks and benefits of chest physiotherapy in ventilated children are unknown. It is important to identify which patients are likely to benefit most and in which situations chest physiotherapy may present a significant risk.
Aim: To identify and understand the risk factors for instability and harmful events which may occur due to chest physiotherapy in children on intensive care.
Design/Methods
Work Package 1
Phase 1 - An anonymous, electronic survey will be sent to all UK physiotherapists who work in paediatric critical care. Information will be collected about physiotherapy practice, referrals, and risk factors assessed and monitored.
Phase 2 - Interviews with 18-27 physiotherapists will take place. The findings from phase 1 will guide the questions. Phase 2 will provide a more in-depth understanding about physiotherapy decision making and management of risks.
Work Package 2
This part of the study will quantitatively assess the effects of chest physiotherapy and identify risk factors for instability. Routinely collected data from the three intensive care units at Great Ormond Street Hospital will be used. No contact with patients/families will be required, and no change to care will occur. Data from approximately 1000 patients will be collected over one year. Health related measures (e.g. oxygen levels) will be recorded before and after chest physiotherapy.
详细描述
Research Questions
- What is current chest physiotherapy practice within UK paediatric intensive care units?
- How do physiotherapists make decisions regarding provision of chest physiotherapy in UK paediatric intensive care units and what other factors influence this decision making?
- What do physiotherapists perceive to be risk factors for physiological instability and adverse events and how do they manage these?
- What is the prevalence of physiological instability and adverse events associated with chest physiotherapy in ventilated children?
- What are the risk factors/characteristics of children who display instability and/or adverse events associated with chest physiotherapy?
- What is the long term impact on the child of instability and adverse events associated with chest physiotherapy?
WORK PACKAGE 1
Phase 1 A descriptive, cross sectional study investigating current chest physiotherapy practice in paediatric intensive care units.
Sample The subject group is physiotherapists working within the 28 NHS PICUs in the UK. Using information from a local benchmarking study which investigated physiotherapy staffing levels on seven UK PICUs, a total of 33 physiotherapy staff was reported, providing an average of four per site. Extrapolating this for the 28 national centres gives an approximate population size of 112 physiotherapists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated and mechanically ventilated
- •Receiving chest physiotherapy
- •0-4 years of age
- •First four days of mechanical ventilation
排除标准
- •Newborn premature babies (currently <36 weeks gestation)
- •Patients requiring mechanical circulatory support
- •Patients not for escalation of care or not receiving active treatment
结局指标
主要结局
Oxygenation
时间窗: Change in baseline Sp02 for 30 minutes before chest physiotherapy and 30 minutes after
Work package 2 - Arterial oxygen saturations (SpO2), measured non-invasively by a finger pulse oximeter.
次要结局
- Presence of Adverse Events(30 minutes after chest physiotherapy)
- Heart rate(Change in baseline HR for 30 minutes before chest physiotherapy and 30 minutes)
- Mean blood pressure(Change in baseline HR and MBP for 30 minutes before chest physiotherapy and 30 minutes)