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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:
Inclusion criteria:
Exclusion criteria:
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):
CXR/US scores:
B. Secondary (subsidiary):
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.
Length of Hospital Stay (days)
Status at discharge (ICT removed or not)
Patients reported outcomes:
Full description
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:
Exclusion criteria:
Sample Size Calculation:
The 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.
-Study tools :all patients will be subjected to:
Demographic data (age, gender) and clinical data (including comorbidities -such as underlying COPD, D.M, HTN, cardiac, hepatic, or renal diseases, immunodeficiency or administration of immunosuppressive therapy- symptoms and their duration, time to admission, time before ICT insertion and duration of antibiotics used) will be collected and documented.
Laboratory testing:
Radiological studies before and after intervention:
i) Chest X ray (CXR) PA/Lateral film. ii) Contrast-enhanced CT chest if deemed necessary by the MDT. Data about extent of the effusion, presence of loculi or pleural thickening, as well as the underlying lesions (pneumonia, mass, nodules) will be documented iii) Chest US:
Curvilinear US probe (Samsung Madison CO-LTD.42 .Teheran-ro-108-gil.Gangnam-gu. Seoul. Korea) that generates a frequency range of 2-5 MHz which has great penetration but lower resolution .
Patients are to be examined in the supine and sitting positions, arms raised and hands placed at the back of the head to expand the intercostal spaces and rotate the scapula outward. Examination will be performed systematically through the intercostal spaces in six vertical lines which are mid clavicular, anterior axillary, mid axillary, posterior axillary, mid scapular and paravertebral .and will cover 8 zones in each lung side (supra-mammary, mammary ,infra-mammary, upper axillary ,lower axillary ,supra-scapular ,inter-scapular , infrascapular ) .
Sonographic Findings (include fluid volume, fluid echogenicity, pleural thickening, findings demonstrating the underlying pneumonia (hyperechoic comma-shape artifacts representing air bronchogram/C profile), other incidental findings (nodules, hypoechoic lesions).
- Fluid volume: First, the maximal inter-pleural distance at posterior-lateral Alveolar and pleural syndrome (PLAPS) point is measured during expiration in a semi-recumbent position. Then, the volume of the pleural fluid will be calculated using Balik's Formula where .
V(ml)= 20 x Distance (mm)
- Echogenicity: Effusion is defined as anechoic when it is echo-free, as complex non-septate when echogenic material is inside the effusion, and as complex septate when floating fibrin strands or septa are found inside the effusions.
Assessment of Mortality and Morbidity Risks:
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 . 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 .
Assessment of Fitness for Anesthesia and Surgery: ASA score (American Society of Anesthesiologists Physical Status ) It is a standardized way to assess a patient's overall health and fitness before surgery. It uses a scale of I to VI, with I being a healthy patient and VI being a deceased organ donor. An "E" is added to the number if the procedure is an emergency. According to age, diseases severity, associated comorbidities, the anaestheology team assign the patient into one of six classes that define the patient's fitness status in a descending rank.
Anesthesia:
The type of the anesthesia that will be administrated to the patient (general or regional) will be documented, as well as the drugs used during anesthesia as (inhalational anesthetics like sevoflurane, and intravenous agents like Propofol and remifentanil).
7- VATS technique:
• Materials :
The following equipment is used to perform a VATS:
1-5 or 10 mm high-resolution fiber-optic thoracoscopy with a 0° or 30° lens 2-A light source with a cable 3-Video monitors 4-Thoracoscopic instruments (scissors, hook or straight-blade cautery, biopsy forceps, grasper, and dissector) 5-Endoscopic stapler if resection is planned 6-Trocars 7-Thoracotomy tray (to convert to open procedure if needed) 8-Chest tubes and drainage devices 9-Sterile gloves, gowns, and drapes 10-Double-lumen endotracheal tube
Procedure steps :
Debridement technique :
The aim of debridement (removal of pus, debris, granulation tissue) is to remove as much as possible of the empyema biofilm while freeing the lung from any loculations.
Following debridement and flushing the pleural cavity by warm saline, the attending anaesthiologist is to modify the ventilatory settings to attain the maximally allowed degree of lung expansion (TV criteria/peak/plateau/PV curve). Then, instillation of saline to obliterate the pleural cavity until saline leaks back from the operating port. If leakage starts after instillation of ≤200 cc. (obliteration of the whole pleural cavity including the cost phrenic angle will be assumed, lung is to be considered sufficiently expanded, and VATS will be withheld at debridement step. On the other hand, if leakage starts after instillation of ≥ 200 cc, lung entrapment and failure of expansion will be assumed, and surgery will proceed to VATS decortication to achieve reasonable lung expansion.
Decortication technique :
- For cases with lung entrapment by thick visceral peel or clotted hemothorax, irrigation with warm saline is to be done; breaking up the fine adhesions, the surgeon will take off the thick visceral peel over the lung surface, opening the fissures using combination of blunt and sharp dissection leaving the parietal pleura.
- A long thoracoscopy instruments are to be used for dissection, evacuation of pus and removal of the visceral peel at the surface of the lung. Instruments will be introduced below the lens in cases of uniport procedure. Two ports VATS will be used early in this series by adding another 3-4 cm incision in the 3rd or 4th intercostal space anterior axillary line, scope will be introduced through the lower port and instruments will be introduced through the other.
- After performing decortication, a warmed saline solution for flushing again inside the chest cavity through a 50-cc syringe for irrigation then suctioned after anesthetist start to ventilate this side and air leak was checked.
-Decortication will be considered completed when near full lung expansion takes place with anesthetist inflating the lung with pressure between 30 and 35 mmHg. Failure to get the whole lung inflation needs a revision of the decortication and either continuing VATS or converting to open surgery depending on the comfort of the operator.
8-Post-Operative Care:
ICT insertion :
- Tools: 2 hemostats, nylon suture (0 or 0-1), scalpel size (11blade), suction apparatus, water seal drainage, chest tube ranges from 28-32 French for Para pneumonic effusion.
Recovery from anesthesia:
Awaken a patient after general anesthesia by gradually reduce and eventually stop the anesthetic medications. The patient will then be monitored closely as they naturally wake up and regain consciousness, breathing on their own.
• Site of admission: All Patients will be sent to the ward or the intermediate care unit, as a part of the institution's protocol.
• Analgesia: According to pain ladder score :
The original ladder mainly consisted of three steps:
1-First Step: Mild pain: non-opioid analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants.
2-Second Step: Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics and with or without adjuvants.
3-Third Step: Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvant.
Adjuvants, also called co-analgesics, include antidepressants, including tricyclic antidepressants (TCAs) such as amitriptyline and nortriptyline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine, anticonvulsants like gabapentin and pregabalin, topical anesthetics (e.g., lidocaine patch), topical therapies (e.g., capsaicin), corticosteroids, bisphosphonates, and cannabinoids .
• Early mobilization and physiotherapy will be encouraged in all patients until discharge.
9-Follow Up protocol postoperative: i) Amount of drained fluid daily in cc, color (serous, pus, blood or serosanguinous) (pre-operative and post-operative).
ii) CXR and Chest US in day prior to surgery and 1 day postoperative then at discharge :
• Chest X-ray is to be scored into: No change in the first X-ray before VATS takes score ( 0) Less than 1/3 improvement/lung expansion takes score(1). Improvement between 1/3 and 2/3 takes score (2). More than 2/3 improvement without complete clearance of effusion takes score(3).
Complete radiological clearance/complete lung expansion takes score(4)
No change takes score(0). Dissolution of adhesions in some regions takes score(1). Dissolution of adhesions in all regions with residual pleural affection takes score(2).
Total adhesion dissolution without residual pleural lesion takes score(3). iii) Presence of air leak at discharge. iv) Visual analogue Sore (VAS): It is a scale from 0-10 cm with 0 value on the left side representing maximum comfort and 10 representing maximum discomfort on the right side will be assessed at in day prior to surgery and 1 day postoperative then at discharge .
-Research outcome measures:
Primary (main):
CXR/US scores:
-Failure: Chest X-ray scoring 0 and chest US scoring 0.
B. Secondary (subsidiary):
• 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.
Length of Hospital Stay (days)
Status at discharge (ICT removed or not)
Patients reported outcomes:
Complication : minor as bleeding, wound infection, surgical emphysema, postoperative blood transfusion or major as worsening of pneumonia, sepsis, persistent air leak, need to re-exploration.
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Inclusion criteria
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
95 participants in 2 patient groups
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Central trial contact
Olfat Mostafa El Shinawy, MD; Hussein khairy abd elaziz, MD
Data sourced from clinicaltrials.gov
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