跳至主要内容
临床试验/NCT03112811
NCT03112811Unknown不适用

Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min

研究概览

简要总结

The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Child < 10 kg
  • •Hospitalization in the pediatric intensive care
  • •Presence of an atelectasis to the radiography and/or to the lung ultrasound
  • •Presence of an invasive ventilation or a non-invasive ventilation
  • •Criteria of cardio-respiratory stability met

排除标准

  • •Absence of the physiotherapist and the radiologist referents (by ex: at night)
  • •Prematurity
  • •Neuromuscular disease
  • •Ventilation by high-frequency oscillation
  • •Extraphysical Assistance
  • •Patient cardiac post-surgery with closure postponed from the thorax. In the closure of the thorax, the patient becomes eligible
  • •Intracranial pressure > 20 mmHg or clinical signs of intracranial high blood pressure

研究组 & 干预措施

Intubated infant

Experimental

干预措施: Autogenic drainage (Device)

Intubated infant

Experimental

干预措施: Intrapulmonary percussive ventilation (Device)

Extubated infant

Experimental

干预措施: Autogenic drainage (Device)

Extubated infant

Experimental

干预措施: Intrapulmonary percussive ventilation (Device)

结局指标

主要结局

Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Change from baseline respiratory frequency at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Change from baseline systolic blood pressure at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Change from baseline expiratory CO2 at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Change from baseline Atelectasis scores at 20 min

时间窗: Baseline and at 20 min

Each atelectasis has a thoracic ultrasound

Change from baseline diastolic blood pressure at 20 min, 30 min, 50 min, 80 min

时间窗: Baseline and at 20 min, 30 min, 50 min, 80 min

Stability of the parameters

Compare the atelectasis scores

时间窗: Baseline between thoracic ultrasound and chest x-ray

Compare the atelectasis scores between thoracic ultrasound and chest x-ray

次要结局

  • Number of unexpected events(At 20 min)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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