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临床试验/NCT03804385
NCT03804385Unknown不适用

Primary Spontaneous Pneumothorax and Different Types of Surgical Management

Assiut University4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3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
50
试验地点
4
主要终点
Duration of Intercostal tube in days

研究概览

简要总结

the different surgical management in patients with primary pneumothorax 0 Objective 1: Identify risk factors that are predictive of the need for surgical intervention.

  • Objective 2: Determine the value of management strategies in terms of hospital stay
  • Objective 3: Assess outcomes and postoperative results including symptom relive ,or recurrence or post-operative complications .

详细描述

pneumothorax is defined as air or gas accumulated in the pleural cavity. Spontaneous pneumothorax can be classified as either primary or secondary. Primary spontaneous pneumothorax , which is defined as a pneumothorax without underlying lung disease, predominantly occurs in young, thin males. It is usually caused by ruptured pleural blebs or bullae. Secondary spontaneous pneumothorax usually occurs in older people with underlying pulmonary disease, such as emphysema or asthma, acute or chronic infections, lung cancer, and congenital diseases including cystic fibrosis, catamenial pneumothorax , or lymphangio-leiomyomatosis .

The age-adjusted incidence of Primary spontaneous pneumothorax is from 7.4 to 18 per 100 000 population per year in males, and from 1.2 to 6 per 100 000 population per year in females. It usually occurs in tall, thin males of 10 to 30 years old. Less often does it occur in people at the age of more than 40 years. Primary spontaneous pneumothorax might be associated with some congenital disorders such as Marfan's syndrome, or some environmental factors such as smoking. Primary spontaneous pneumothorax usually occurs at rest. Approximately 10% of patients with Primary spontaneous pneumothorax have a positive family history. Smoking is also regarded as a precipitating factor for Primary spontaneous pneumothorax. The relative risk of pneumothorax ranged from 7 to 100 times higher in light to heavy smokers Most authors believe that Primary spontaneous pneumothorax results from spontaneous rupture of a sub-pleural bleb or bulla. However, only a portion of patients with Primary spontaneous pneumothorax could be found with blebs or bullae in imaging or at the time of surgery. Other mechanisms may be considered, such as increase in pleural porosity secondary to inflammation. The development of bullae, blebs, or pleural porosity might be related to many factors, such as distal airway inflammation, distal bronchial tree anomaly, disorders of connective tissue formation, local ischemia, and malnutrition.

Primary spontaneous pneumothorax usually occurs at rest, and presents with acute onset of local pleuritic chest pain accompanied by dyspnoea. This pain may be mild or severe, sharp and steady ache in character, and usually resolves within 24 h even though pneumothorax still exists. On physical examination, decreased air entry on auscultation, decreased chest wall movement on inspection, hyper-resonance (tympanic) on percussion are most often detected in patients with large pneumothorax (free air occupies more than 15% to 20% area of hemi thorax). Reflex tachycardia can be found in most patients in response to discomfort or circulating or respiratory compromise. Tension pneumothorax should be suspected if severe tachycardia, cold sweating, hypotension, or cyanosis has developed. Blood gas analysis in patients with large pneumothoraces may reveal increased alveolar-arterial difference in oxygen partial pressure (PA-aO2) due to increased intrapulmonary shunt from the collapsed lung.

Most Primary spontaneous pneumothorax cases are confirmed by upright posteroanterior chest radiograph, which can be used to assess the pneumothorax size with good accuracy. A pleural line with or without an air-fluid level can be seen in the chest radiograph, but sometimes it is difficult to detect these signs, especially in patients with small pneumothoraces, emphysema, or poor exposure of the film. Expiratory chest radiographs have no diagnostic value for patients with Primary spontaneous pneumothorax.

Computed tomography (CT) of the chest can be used to detect patients with small penman-thorax (less than 15% area of hemi thorax). In addition, CT can provide more detailed information to assist in the subsequent management. Findings which can be noted include the number, size, and location of bullae/blebs (ipsi- or contra-laterally), as well the possibilities of pleural adhesion, pleural fluid accumulation, and possible underlying pulmonary diseases. For more than 90% of patients with Primary spontaneous pneumothorax, pathological lung changes can be detected by CT. The most common type is few (n<5) and small (<2 cm in diameter) blebs, followed by mixed blebs and bullae (>2 cm in diameter).

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presented with primary pneumothorax at Assiut University Hospital patients above 18 years and less 40 years Male or Females

排除标准

  • Patients with other chest pathology including :
  • emphysema
  • acute or chronic infections
  • lung cancer,
  • congenital diseases including( cystic fibrosis, catamenial pneumothorax, or lymphangioleiomyomatosis)

研究组 & 干预措施

intercostal tube

Other

insertion of intercostal tube is surgical operation used in pneumothorax

干预措施: intercostal tube (Procedure)

结局指标

主要结局

Duration of Intercostal tube in days

时间窗: 2 weeks

last more in open thoracotomy

Duration of air leakage in days

时间窗: 2 weeks

last more in intercostal tube than in open thoracotomy

pain score

时间窗: 1 week

high pain score in open thoracotomy than in intercostal tube

recurrence after one year

时间窗: one year

by radiological intervention on after one year follow up

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

ahmed samir yussef

Principal Investigator

Assiut University

研究点 (4)

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