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临床试验/NCT06083077
NCT06083077撤回不适用

Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
23
试验地点
2
主要终点
Esophagal product time pressure

研究概览

简要总结

Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress.

The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction.

Infant < 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.

研究设计

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

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant < 6 months
  • Admitted to the PICU for less than 48 hours
  • With a diagnosis of bronchiolitis
  • With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support
  • With a naso or oro gastric tube for feeding
  • With written informed consent from parents or legal guardians

排除标准

  • Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease
  • Contraindication to the use of a gastric tube
  • recent abdominal or thoracic surgery
  • investigator able to perform physiological recording not available
  • Patient who is not affiliated (or does not benefit from) to a national social security system

结局指标

主要结局

Esophagal product time pressure

时间窗: 1 hour

Average over 100 consecutive cycles of esophageal product time pressure value

次要结局

  • End expiratory lung volume(1 hour)
  • Diaphragmatic product time pressure(1 hour)
  • Esophagal and diaphragmatic swing(1 hour)
  • Distribution of ventilation : center of ventilation(1 hour)
  • Time ratio(1 hour)
  • EDIN scale (Newborn Pain and Discomfort Scale)(1 hour)
  • modified wood asthma score (mWCAS)(1 hour)
  • TcPCO2(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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