Preoperative Prediction of VATS Strategy in Parapneumonic Effusion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Assessment the radiological signs of lung expansion
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) has revolutionised management of complicated parapneumonic effusion ( PPE). So our study is prospective cohort study will be conducted at Departments of Chest Diseases and Cardiothoracic Surgery, Assiut University Hospitals
- Aims: to determine the frequency of which VATS technique is needed (decortication versus debridement ) and to verify whether baseline RAPID score and pleural US parameters can predict which VATS procedure (decortication vs. debridement) in patients with complicated PPE will need, upon intra-operative exploration to compare the time to ICT removal after lung expansion and length of hospital stay in patients with PPE undergoing VATS via either debridement or decortication approach .
- Subjects: All patients with PPE presenting with suggestive symptoms,signs or radiological studies which display compatible patterns of PPE:
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Inclusion criteria:
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Age > 18 years
-
Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) >200 IU/L) in a patient with clinical evidence of infection .
-
Failed resolution of parapneumonic effusion.
-
Exclusion criteria:
-
Patients unfit for/ or declining surgical intervention.
-
Iatrogenic or traumatic pyothorax.
-
Haemothorax or chylothorax regardless the etiology.
-
Exudative pleural effusion due to medical conditions other than pneumonia .
- Sample size was calculated using Epi-info software version 7.2.5.0. The total sample size needed to detect such an estimate with 95% confidence level and 10% margin of error will be 95 patients
- Research outcome measures:
- Primary (main):
- Number of the patients who will receive either VATS technique (and the respective percentage in relation to the total patients)
- Preoperative Adjusted RAPID score and US findings (fluid volume, echogenicity, pleural thickening, consolidation and other incidental findings).
- Assessment the radiological signs of lung expansion
CXR/US scores:
- Failure: Chest X-ray scoring 0 and chest US scoring 0.
- Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1.
- Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3.
B. Secondary (subsidiary):
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Time to ICT removal (days). ICT tube will be removed based on the MDT joint decision according to the patients' individual course. Tube removal is contemplated upon clinical resolution, complete fluid drainage, full lung expansion and absence of pleural air in CXR, in the absence of air leak, chest ultrasound to assess if there is residual pleural effusion.
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Length of Hospital Stay (days)
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Status at discharge (ICT removed or not)
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Patients reported outcomes:
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Postoperative pain (VAS) at discharge time
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Resumption of usual activities (self-care routine with assistance - unassisted self-care- other activities indoors- independent indoors and outdoors activities) by attending the patient to the hospital within 30 days post discharge.
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Mortality rate within 30 days postoperative.
详细描述
- Type of the study: Prospective Cohort Study.
- Study Group: VATS debridement versus VATS decortication.
- Study Setting: Departments of Chest Diseases and Cardiothoracic Surgery, Assiut University Hospitals.
- Study subjects:
All patients with PPE presenting with suggestive symptoms (acute onset fever, cough, expectoration ± pleuritic chest pain or hemoptysis), signs (fever, increased TVF, Bronchial breath sound, localized crepitation) or radiological studies (CXR and pleural US ±CT Chest) which display compatible patterns (semihomgenous opacity with blunting of the costophrenic angle, homogenous opacity suggestive loculated effusion, air bronchogram):
-
Inclusion criteria:
-
Age > 18 years
-
Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyzer), low glucose level (⩽3 mole/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) >200 IU/L) in a patient with clinical evidence of infection .
-
Failed resolution of parapneumonic effusion:
-
Exclusion criteria:
-
Patients unfit for/ or declining surgical intervention.
-
Iatrogenic or traumatic pyothorax.
-
Haemothorax or chylothorax regardless the aetiology.
-
Exudative pleural effusion due to medical conditions other than pneumonia (suspected or proven Para malignant effusion, associated pulmonary embolism, autoimmune, pancreatic or esophageal disease, gynecological disorder, and drug-induced pleural effusion).
-
Sample Size Calculation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients diagnosed with PPE who are confirmed by (aspiration of frank pus from pleural cavity, positive culture for bacterial infection, pleural fluid with a pH ⩽7.2 (measured by blood gas analyser), low glucose level (⩽3 mmol/L or ⩽55 mg•dL-1), lactate dehydrogenase (LDH) >200 IU/L) in a patient with clinical evidence of infection [6].
- •Failed resolution of parapneumonic effusion:
- •Given a patient-to-patient variability in response to medical treatment, therapeutic pleurocentesis and ICT drainage, a MDT involving consultant cardiothoracic surgeons and consultant pulmonologist are to discuss enrolled cases individually , reach consensus, and declare failure of medical treatment or ICT drainage and need for surgical intervention , based on combination of clinical , laboratory, and radiological parameters (persistence of fever. Elevated Wbcs, respiratory symptoms, pleural fluid loculi inaccessible by ICT, lung entrapment despite complete drainage of fluid or large bronchopleural fistula
排除标准
- •Patients unfit for/ or declining surgical intervention.
- •Iatrogenic or traumatic pyothorax.
- •Haemothorax or chylothorax regardless the aetiology.
- •Exudative pleural effusion due to medical conditions other than pneumonia (suspected or proven Para malignant effusion, associated pulmonary embolism, autoimmune, pancreatic or oesophageal disease, gynaecological disorder, and drug-induced pleural effusion).
结局指标
主要结局
Assessment the radiological signs of lung expansion
时间窗: perioperative
CXR/US scores: * Failure: Chest X-ray scoring 0 and chest US scoring 0. * Partially successful: Chest X-ray scoring 1 or 2 and chest US scoring 1. * Successful: Chest X-ray scoring 3 or 4, and chest US scoring 2 or 3.
Preoperative Adjusted RAPID score and US findings
时间窗: the baseline
Preoperative Adjusted RAPID score which determine what is the technique will be used ( decortication or debridement ) as shown : Adjusted RAPID score is a simple and easily calculated score that assesses mortality risk for patients with pleural infections. The score entails 8 parameters (Renal (urea), age, fluid purulence, infection source, dietary (albumin), diabetes mellitus, renal insufficiency (dialysis), immunosuppression are assigned as seen in Figure(1). The total adjusted RAPID score (0-10 points) represents the sum of the points assigned to the 8 parameters together, on the basis of which the patient's risk for 90 days mortality is determined . Risk categories : score 0-2 low risk score 3-4 intermediate risk score 5-7 high risk score 8-10 very high risk
次要结局
- Time to ICT removal (days)(through study completion, an average of 30 days)
研究者
Hamed Farrag Qenawy
assistant lecturer
Assiut University