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临床试验/NCT02881632
NCT02881632已完成不适用

Pneumacare SLP Validation in Infants and in Clinical Bronchiolitis: Validation of Structured Light Plethysmography (SLP) in Healthy Infants and in Infants With Clinical Bronchiolitis

University Hospitals of North Midlands NHS Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11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
60
试验地点
1
主要终点
Difference in SLP measurements between infants.

研究概览

简要总结

A cohort observational study to characterise baseline Structured Light Plethysmography (SLP) outputs in infants with bronchiolitis and examine response to treatment using the Thora3DiTM

详细描述

Viral illness, particularly chest infection causing breathing difficulty in infants and children is the commonest reason for admission to hospital. At present, there are no objective measurements of the degree of breathing difficulty.

This is because current objective tests of breathing difficulty requires the patient to cooperate and actively perform the tests. This is not possible in babies and very challenging in young children. SLP is a noncontact, effort independent technique for measuring the rate of breathing, the amount of chest expansion and the relative contribution of chest and abdomen to the work of breathing. Measuring these parameters which are known to vary with increasing breathing difficulty will allow us to make objective assessments of breathing difficulty. This study proposes to validate this technique in babies aged 02 years who are healthy and in babies with clinical viral bronchiolitis. The Investigators intend to demonstrate that the technique is feasible in this young age group and that the investigators will be able to demonstrate clinically valid differences between normal and ill babies and also demonstrate measurable differences with the evolution of the clinical illness.

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 Minute 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
  • An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
  • Parents unable to consent/comply with trial protocol
  • An inpatient for over 24hrs (AVB patients only)

结局指标

主要结局

Difference in SLP measurements between infants.

时间窗: Measured upto 7 days

Difference in SLP measurements between infants. SLP provides a measure of the chest and abdominal movement (Respiratory effort) of the subjects, the movement signal will be used to quantify clinically relevant tidal breathing parameters such as timing indices: Ti (Time of inspiration), Te ( Time of expiration) and Ttot (Ti+Te). Parameters will be quantified for each recorded SLP signal (averaged) from each infant, and then used to compare between infants with bronchiolitis and healthy babies.

次要结局

  • Changes in SLP measurements in infants given additional breathing support.(Measured upto 7 days)
  • Changes in SLP measurements in infants during their clinical course.(Measured upto 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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