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临床试验/NCT05791877
NCT05791877已完成不适用

Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy

Nemours Children's Clinic2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2023年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Presence of pulmonary dysfunction

研究概览

简要总结

This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

详细描述

This project proposes the utilization of a novel non-invasive real-time breathing sensor - pneuRIP- to measure pulmonary function (PF) in children with high-level cerebral palsy. Currently the standard measures of PF such as spirometry and peak flow meters are too strenuous for children and those with severe CP, as a result they have low compliance rates. The pneuRIP does not require active user participation and can passively measure PF. It consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. The pneuRIP yields indices of work of breathing (WOB) which includes the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.

The WOB indices provide a screening tool for pulmonary diagnosis and treatment, decrease the risk for pneumonia and respiratory illness, and has the potential to act as a marker for scoliosis in children with high-level CP.

The impact on the field will be to have a simple and fast way to measure pulmonary function in children and adults with severe CP and correlate this to measures of function and scoliosis severity as the effects of scoliosis, which is common in CP, on pulmonary function is unclear. Measures of motor function are classified by the Gross Motor Functional Classification System (GMFCS), ranking from I to V, with worsening disability from near normal gait in Type I to complete wheelchair use in Type V. This project will address GMFCS levels IV and V which includes people using wheelchairs. The two specific aims are a) Measure WOB indices non-invasively using the pneuRIP sensor in children with CP who use a wheelchair (GMFCS level IV, V) and validate the use of WOB indices as a screening test for pulmonary dysfunction., 2) Determine the correlation between WOB indices and the degree of scoliosis using the pneuRIP sensor in 250 children with CP who use a wheelchair (GMFCS level IV, V).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects should have cerebral palsy a GMFCS levels IV, V

排除标准

  • 未提供

研究组 & 干预措施

cerebral palsy group

Experimental

Respiratory sensor will measure breathing in patients with Cerebral palsy

干预措施: pneuRIP (Device)

结局指标

主要结局

Presence of pulmonary dysfunction

时间窗: 1 month

The presence of pulmonary dysfunction will be recorded for each subject. Presence will be determined clinically by the physician. Pulmonary dysfunction can take the form of pneumonia, ineffective airway clearance or atelectasis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tariq Rahman

Principal Research Engineer

Nemours Children's Clinic

研究点 (2)

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