Clinical Research Directory

Comparing Chest Ultrasound and CT in Differentiating Pleural Effusions

Pleural effusion is a condition where excess fluid builds up in the space between the lungs and the chest wall. To properly treat this condition, doctors must determine if the fluid is a "transudate" (usually resulting from systemic conditions like heart failure or liver disease) or an "exudate" (often resulting from local issues like infections, inflammation, or cancer). The standard method to classify this fluid involves inserting a needle into the chest to draw out a sample for laboratory testing, a procedure known as thoracentesis. While laboratory fluid analysis is highly accurate, the needle procedure carries some inherent procedural risks. This observational study aims to evaluate whether non-invasive imaging tests, specifically chest ultrasound and computed tomography (CT) scans, can accurately determine if the fluid is a transudate or an exudate. Researchers will enroll adult patients presenting with pleural effusion at Assiut University Hospital. As part of their diagnostic workup, participants will undergo a chest ultrasound, a chest CT scan and a standard diagnostic thoracentesis (fluid draw) within 24 to 48 hours of each other. The study will then compare the features seen on the ultrasound and CT scans against the laboratory fluid analysis (the current gold standard) to see how well the non-invasive imaging performs in identifying the specific type of pleural effusion.

Pleural Effusion Biomarkers in Lung Adenocarcinoma Patients

This project aims to assess the expression levels of novel molecular markers identified through screening in clinical samples of malignant pleural effusion, to evaluate the feasibility and clinical utility of these markers as potential diagnostic genes for lung adenocarcinoma.

Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions

This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.

Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial

This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used. The clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.

Study of the Benefits of Virtual Reality Headsets for Reducing Anxiety in Patients Treated for Pleural Effusion or Pneumothorax Using Small-bore Chest Drainage Tubes

Pleural effusion and pneumothorax are common conditions encountered in pulmonology departments and may require chest drainage. However, the chest drainage procedure can cause anxiety in patients, leading to discomfort during the procedure. The use of virtual reality (VR) for anxiety reduction has shown promising results in various medical contexts.

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.

16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy

The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasive pulmonary lobectomy and/or segmentectomy.

Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion

Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.

Virtual Reality: Distraction During Small Bore Intercostal Chest Drain Insertion

Intercostal chest drain (ICC) insertion is a common procedure done worldwide to treat and diagnose pleural disease. It is used to evacuate fluid, blood, or air in the cavity from a myriad of causes namely pleural effusions of different etiologies, empyema, hemothorax, chylothorax and pneumothorax. It also functions as a route for antibiotics, pleurodesis and fibrinolytics. Hippocrates, whose practiced medicine 2,400 years ago, is often credited with being the first to insert a metal tube into the pleural region to drain fluid. It wasn't until the 19th century that a closed drainage system was properly documented in the literature, although open drainage remained to be the norm for quite some time. In the past, large-bore tubes (24-32 F) were recommended in nearly all circumstances and were inserted using a blunt dissection technique. However, during the past two decades, small-bore catheters have become increasingly popular. They were first used to drain abdominal collections and have now been adopted for use in draining the pleural cavity utilizing the needle and guide wire Seldinger procedure, typically with radiological guidance. In addition to that, Seldinger technique allow us to insert the catheter at lower intercostals spaces without injury to the diaphragm or abdominal organs, thereby ensuring patient safety.

Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency

Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results. Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently , in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures. British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions. The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement. There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion.

Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU

Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.

Intrapleural Catheter Daily Versus Three Times a Week Drainage

The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.

Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema

The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection. The investigators are trying to learn: * Does using the medicine once a day work just as well as using it twice a day? * Are there any differences in outcomes between patients who get the medicine once a day versus twice a day? * Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given? Participants will: * Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung. * Be asked to give permission to join the study. * Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.

The ACES Study for Aseptic Pleural Effusion

The study will enroll recurrent aseptic pleural effusion patients who are designated by their physician as needing treatment to control the fluid. Baseline assessment will include a history and physical, chest imaging and quality of life questionnaires. After ACES implantation, patients will remain under hospital care for general observation as per standard-of-care before being discharged home with access to electronic diaries for tracking pain and dyspnea.

ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG

This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL). NEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures. This study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavity in a controlled fashion, reducing negative pressure and potentially reducing pain, improving drainage tolerance, and minimising the need for repeated procedures. Pleural effusion drainage is a common procedure in patients with advanced malignancy or chronic pleural disease. In patients with NEL, fluid removal creates a vacuum effect within the pleural space due to the inability of the lung to fully re-expand. This negative pressure is a key driver of severe procedural pain, vasovagal symptoms, and premature cessation of drainage. It may also necessitate multiple drainage procedures over a short period. Currently, there are limited strategies to mitigate this problem, often relying on stopping the procedure prematurely or on analgesia, which does not address the underlying cause. This trial evaluates the introduction of atmospheric air into the pleural space during drainage as a pragmatic, low-cost solution. The technique uses standard equipment - a 3-way tap - allowing air to be introduced safely and intermittently during drainage to reduce the vacuum effect. Patients undergoing therapeutic pleural drainage with an indwelling catheter or chest drain will be randomised in a 2:1 ratio to: Standard drainage care (control group) Drainage with intermittent controlled air introduction (intervention group) Air entrainment will be performed by briefly opening the 3-way tap to atmospheric air during drainage up to five times, based on patient discomfort and operator discretion. This aims to equalise pleural pressures, reduce pain, and improve drainage outcomes. Randomisation is weighted 2:1 towards the intervention group to maximise the number of patients who may benefit, following favourable preliminary data. Both patients and outcome assessors will be blinded to group allocation. Outcomes collected Primary Outcomes: Patient-reported pain scores during drainage - Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent a worse outcome. Secondary Outcomes: Volume of pleural fluid drained Number of pleural drainage procedures required Time interval between drainage procedures Incidence of complications (e.g., pneumothorax, re-expansion pulmonary oedema, infection) Reasons for incomplete drainage, including the presence and characteristics of non-expandable lung Patient-reported satisfaction with the drainage procedure

First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis.

Non randomized study with two groups. The study group includes patients with suspected malignant pleural effusion, in whom the investigation of pleural effusion begins directly with pleural biopsy by Local Anesthesia Thoracoscopy (LAT). The Control Group includes patients who come to the same hospital and are treated with the Standard of Care (SOC) strategies were used. Efficacy of LAT, Sensitivity, Hospitalization, time to diagnosis and general safety and comfort of the groups' subjects will be assessed.

Improvement to Perform Thoracocentesis After a Specific Training in Medical Students With the Supervised Use of an Augmented Reality Simulator

Monocentric study, aiming to assess the improvement of medical students to perform a first-time thoracentesis after training using a specific training using an augmented virtual reality simulator, versus standard training. Study population: medical students from the department of Respirology (University hospital of Strasbourg), performing their first thoracocentesis in patients having an indication for a first-time thoracocentesis. This is not an interventional study, no change in patient course being induced because of the study. After the procedure: use of specific surveys for the patient and for medical students to assess the patient's pain, the patient and the medical student level of anxiety, and the student ability during the procedure.

Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.

Strategy for Prompt and Effective Thoracentesis in the Emergency Department

The SPEEDTAP-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ED) in Central Denmark Region. Patients are randomised to either manual fluid removal in the ED or passively fluid drainage using gravity in the radiology department (standard of care). Primary outcome: time from clinical indication to complete drainage and 188 patients will be included. Key secondary outcomes include length of stay, ED admission to ED discharge and safety end-points.

Comparing the Diagnostic Sensitivity and Specificity of Pleural Fluid N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) and Other Biochemical Gradient Criteria in Distinguishing Heart Failure and Non-heart Failure Related Pleural Effusions (CENTRE Study)

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Chest Drain Insertion Assisted by Virtual Reality

Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\' pain and anxiety

Ultrasound-guided Pigtail Catheter Versus Intercostal Tube Drainage of Non-traumatic Exudative Pleural Effusion

Primary Aims: To compare the performance of pigtail catheter to that of ICT in drainage of pleural effusion of medical aetiology regarding: 1. Various complications(mainly wound pain) that result from either therapeutic approach. 2. Success of complete drainage. 3. Compare the duration needed for complete drainage. Secondary Aims: To evaluate both techniques in terms of: 1. Degree of patient's mobility that either technique permits. 2. Percentage of patients that can be managed on outpatient settings by either approach

Role of Ultrasound Elastography in Pleural Effusion

Diagnostic performance of u.s elastography in pleural effusion