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临床试验/NCT02660203
NCT02660203Unknown不适用

Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial

University Hospital, Tours19 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
19
主要终点
assessment of pleural drainage duration

研究概览

简要总结

Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.

Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.

Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.

The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.

详细描述

Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage, most often for few days (2 to 5 days) until fluid quantity is lower than 50 mL / 24h.

Pleural effusion may cause pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.

Respiratory physiotherapy in such situations has different aims : pulmonary decongestion and reexpansion, aid for drainage and pleural fluid reduction, avoiding complications and preventing vicious attitudes.

These aims are learned in Physiotherapy formation institutes. The forced expiration technic in ipsilateral decubitus is justified by pleural physiology and is used after pediatric surgery without any scientific evidence regarding his efficacy Using pulmonary physiotherapy after pulmonary, mediastinal or pleural surgery for children is not systematic and depends on prescriber without any professional recommendation.

Actually no scientific evidence regarding technical or postural indicates improvement of effusion drainage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 48 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Children 0-4 years
  • In front have a mediastinum or lung surgery (lung segmentectomy or lobectomy or non anatomical lung resection) with pleural drainage, regardless of the type drain
  • Whose parents or the holder of parental authority have signed a consent
  • Whose parents or the holder of parental authority are affiliated to a social security scheme

排除标准

  • chest trauma
  • Oncology (chest tumors, lung metastases)
  • Drained Pleuropneumopathies
  • Spine Surgery
  • Heart surgery
  • Surgery for pectus excavatum
  • Route of anterior surgical approach sternotomy chest kind
  • Patients intubated and / or ventilated
  • Patients with preoperative sepsis

研究组 & 干预措施

forced expiration

Experimental

2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal

干预措施: Forced expiration (Procedure)

control

No Intervention

No session of forced expiration

结局指标

主要结局

assessment of pleural drainage duration

时间窗: 3 days

During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.

次要结局

  • assessment of total amount of pleural liquid drained(3 days)
  • Assessment of pain(3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48)
  • patient's respiratory parameters(3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48)
  • paramedical workload(3 days)
  • Oxygen blood saturation(3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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