Clinical Research Directory

Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting \>30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days after major thoracic surgery.

E-Health-Supported Preoperative Education

In the context of patient education, the integration of mobile applications-an e-health modality-among healthcare professionals and patients has garnered significant attention alongside technological advancements. Mobile applications offer distinct advantages, notably the vast global population capable of accessing and utilizing these digital tools. A study evaluating the impact of mobile applications on the recovery of patients undergoing ambulatory surgery demonstrated that the quality of recovery was superior in the intervention group. In research investigating mobile application-based education following breast cancer surgery, significant improvements were observed in pain levels, affected shoulder functions, and anxiety levels within the intervention group . Among patients undergoing cardiac surgery, 98% of those who received education via a mobile application reported that the application was beneficial to their recovery process . Furthermore, in a study involving a mobile application for patients undergoing heart valve surgery, the intervention group exhibited significantly lower probabilities of hospitalization, emergency department visits, and complications . An integrative review of mobile applications in the health education of surgical patients noted that while research has involved bariatric, orthopedic, colorectal, mastectomy, urological, and neurological surgical patients, there is an emphasized need for further nursing research utilizing emerging communication technologies. To date, no studies evaluating the effectiveness of preoperative education delivered via mobile application for patients undergoing thoracic surgery have been identified. Initiating preoperative preparation for patients scheduled for thoracic surgery is anticipated to positively influence postoperative recovery and quality of life, highlighting the necessity for research in this domain.

CT-Guided vs Conventional DLT Sizing in Thoracic Surgery

This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation

Surgical Prehabilitation on Autonomic Nervous System (TUNE)

This study will be a multicenter interventional randomized trial evaluating the effect of a multimodal prehabilitation program on heart rate variability (HRV). In the same protocol the impact of HRV on hospital length of stay will be identified. One hundred patients aged 18 years or older scheduled for elective surgery will be eligible for enrolment, if they will not present any exclusion criteria. Patients will be randomized with a 1:1 allocation to receive either prehabilitation or standard of care.

Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study

The SAVED LUNG study is a pilot Phase I trial evaluating safety and feasibility of observation versus standard-of-care surgery in operable Stage II-III (excluding N3) NSCLC patients (PD-L1 ≥50%) who achieve complete clinical response following neoadjuvant platinum-doublet chemotherapy and immunotherapy. Participants are randomized to observation or surgery after rigorous restaging, with primary endpoints focusing on safety and feasibility. Secondary objectives include rates of cross-over to surgery, event-free survival, and overall survival, while exploratory endpoints examine ctDNA clearance and its association with clinical response.

Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery

This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries. Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge. The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE). Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.

Thoracic Surgery by SHURUI Single-Port Surgical Robot

The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. The SHURUI SP represents a cutting-edge technology in the field. This system features snake-like surgical instruments utilizing "dual continuum mechanism", which enables precise single-port procedures with wide range of motion and high load capacity. The SHURUI SP has been cleared by the National Medical Products Administration (NMPA) of China for use in urology and gynecology and has completed clinical trials for general surgery and thoracic surgery. It is China's first and the world's second approved single-port surgical robot. Compared to multi-port surgical robots, it can provide patients with less trauma, fewer complications, and faster recovery. The SHURUI SP has also achieved significant breakthroughs in clinical applications. It conducted the world's first randomized controlled clinical trial on single-port robotic urologic surgery and introduced a series of innovative surgical paradigms. These include the world's first single-port sleeve lobectomy, single-port retroperitoneal adrenalectomy, single-port retroperitoneal partial nephrectomy, single-port distal gastrectomy (Billroth I anastomosis), and single-port total gastrectomy. Our centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, investigators have established our centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures. In this study, investigators evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.

Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia

Purpose of the study The goal of this research is to see which of two nerve-numbing techniques-the Rhomboid-Intercostal Block (RIB) or the Thoracic Paravertebral Block (PVB)-works better to control pain after chest surgery (specifically, video-assisted thoracoscopic surgery, or VATS). Both techniques use numbing medication to block pain signals after the operation. Who can participate? The researchers are looking for adults between 18 and 85 years old who are scheduled for a specific type of chest surgery (a 3-port VATS procedure). How will the research happen? Participants will be put into two equal groups by chance. One group will receive the RIB technique, and the other group will receive the PVB technique. Both procedures are done under ultrasound guidance after the completion of surgery, while the patient is still asleep. The pain levels of the participants will be measured at rest and when taking deep breaths at several times during the first 24 hours after surgery. Why is this study useful? This study aims to find out which pain relief method is more effective and if one results in fewer side effects, such as nausea or the need for stronger pain medications (opioids). These results will possibly help doctors provide better comfort to patients recovering from chest surgery in the future.

Sensory Anesthesia Achieved Through Different Paravertebral Block Approaches for Post-Op Pain Management After VATS Lung Resection

Video-assisted thoracoscopic lung resection (VATS) is a minimally invasive surgical approach frequently used in the treatment of lung cancers. The most commonly used analgesic technique for this surgery is the paravertebral block with a single peroperative injection of local anesthetic. However, a recent study conducted at our institution revealed that this approach provided less relief than expected in some patients. In light of these results, it becomes crucial to distinguish between technical failures (absence of sensitive anesthesia) and the intrinsic limits of the chosen regional analgesia technique (pain originating from an unanesthetized area or pain despite the presence of sensitive anesthesia) in order to better relieve patients. This study aims to objectively assess the areas of anesthesia obtained through three methods of paravertebral block to evaluate their respective performance and optimize post-VATS analgesic management.

A Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.

Pulmonary resections are key in treating lung neoplasms, with techniques adapted to tumor size and location. Minimally invasive approaches like VATS have replaced open thoracotomy, but intercostal trocar placement can lead to nerve injury and chronic pain. Robotic-assisted thoracic surgery (RATS) is usually done via a transthoracic (RATS-TT) approach using intercostal trocars. A newer "out of cage" method (RATS-OTC), using subcostal or subxiphoid ports, avoids intercostal access, potentially reducing nerve damage. A French study showed less opioid use and acute pain with RATS-OTC, but chronic pain outcomes are still unknown. At CHUM, a hybrid RATS technique (RATS-TTH) is also used-intercostal for instruments, but with out-of-cage specimen extraction-to limit intercostal trauma.

Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection

This is a large clinical study that compares two different types of anesthesia for patients undergoing a specific kind of minimally invasive lung surgery (thoracoscopic sublobar resection) to remove small, early-stage lung nodules. The study aims to find out if a newer anesthesia method, known as "non-intubated anesthesia" (where patients breathe on their own with the help of a laryngeal mask airway and nerve blocks for pain control), is as safe as the traditional "intubated anesthesia" (which uses a breathing tube and a machine to breathe for the patient). The main goals of the study are, in order: 1. Safety First: To confirm that the non-intubated method does not lead to more lung complications within 30 days after surgery compared to the traditional method. 2. Effectiveness: If it is proven safe, the study will then check if patients receiving the non-intubated anesthesia have a better quality of recovery in the first 24 hours after surgery (e.g., less pain, fewer side effects like a sore throat, and a faster return to normal activities). Approximately 1600 patients from multiple hospitals will be randomly assigned (like flipping a coin) to receive one of the two anesthesia methods. Neither the patients nor the surgeons will be told which group the patient is in when assessing the main outcomes after surgery, to ensure the results are fair and unbiased. The results of this study will provide high-quality evidence to help doctors and patients choose the best and most comfortable anesthesia option for this type of lung surgery.

Comparison of FCV and VCV in One-Lung Ventilation

One-lung ventilation (OLV) is commonly used during thoracic surgery but may negatively affect lung mechanics and gas exchange. Different ventilation strategies are used during OLV, and their effects on respiratory parameters remain an important clinical concern. Flow-controlled ventilation (FCV) is a newer ventilation mode that allows precise control of inspiratory and expiratory flow, potentially improving lung mechanics and gas exchange. Volume-controlled ventilation (VCV) is a widely used conventional ventilation strategy during thoracic anesthesia. The FCVOLVent study is a multicenter, prospective observational study designed to compare the effects of FCV and VCV during one-lung ventilation in adult patients undergoing thoracic surgery. Patients will be ventilated with either FCV or VCV as part of routine clinical practice. The study aims to evaluate respiratory mechanics and oxygenation parameters, including the PaO₂/FiO₂ ratio, airway pressures, lung compliance, and mechanical power during surgery. Data will be collected at predefined time points during one-lung ventilation. The results of this study are expected to provide real-world clinical evidence on the potential advantages and limitations of flow-controlled ventilation compared with volume-controlled ventilation during one-lung ventilation.

Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications

The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications

A Randomized, Controlled Clinical Trial Comparing Remimazolam Besylate Combined With Alfentanil Versus Propofol Combined With Alfentanil for Anesthesia in Thoracic Surgery

Title: A Clinical Study Comparing Two Anesthesia Methods for Chest Surgery Why is this study being done? Chest surgeries (like lung surgery) require safe and stable anesthesia. Currently, a drug called propofol combined with an opioid painkiller (alfentanil) is commonly used. However, propofol can sometimes cause low blood pressure and low oxygen levels. A newer drug called remimazolam may cause fewer of these side effects. This study aims to compare the safety and effectiveness of remimazolam (combined with alfentanil) versus propofol (combined with alfentanil) for anesthesia during chest surgery. What will happen in the study? Patients scheduled for elective chest surgery will be invited to participate. If they agree, they will be randomly assigned (like flipping a coin) to one of two groups: * Group 1: Will receive remimazolam and alfentanil for anesthesia. * Group 2: Will receive propofol and alfentanil for anesthesia (standard care). The anesthesiologist will carefully monitor patients during and after surgery. We will mainly compare how often patients in each group experience two safety issues: low oxygen levels in the blood and low blood pressure. We will also record recovery times, drug doses, side effects, and ask patients and surgeons about their satisfaction. Who can participate? Adults aged 18-65 who are scheduled for elective chest surgery and are in relatively stable health (ASA physical status I-III). Where is the study taking place? This study will be conducted in the Department of Anesthesiology at The First Affiliated Hospital of Xinxiang Medical College, Henan, China. Ethics Approval: This study has been reviewed and approved by the Ethics Committee of The First Affiliated Hospital of Xinxiang Medical College (Approval Number: (2025) Medical Ethics Committee Approval No. 29).

The Construction and Clinical Application of an Integrated Perioperative Management System for Lung Cancer Based on Wearable Devices and Intelligent Platforms

This study aims to develop and evaluate an integrated perioperative management system based on wearable devices and a digital rehabilitation platform for patients with non-small cell lung cancer (NSCLC) undergoing thoracic surgery. By combining preoperative functional assessment using the six-minute walk test (6MWT), continuous perioperative physiological monitoring, and structured postoperative home-based digital rehabilitation, this randomized controlled trial will investigate whether the wearable-based digital management model improves short-term postoperative pulmonary function, functional recovery, and clinical outcomes compared with standard perioperative care.

Biofilm on Chest Drains After Thoracic Surgery: Clinical Impact and Antibiotic Resistance

This prospective observational study aims to investigate the frequency and clinical significance of biofilm formation on thoracic chest drains used after thoracic surgery. Biofilms are structured bacterial communities that adhere to surfaces and can promote infection and antibiotic resistance. In this study, small samples from the tips of chest drains will be collected under sterile conditions at the time of drain removal and analyzed in the microbiology laboratory. The main objectives are to evaluate the relationship between the duration of chest drain placement and the presence of biofilm, and to identify the antibiotic resistance profiles of microorganisms isolated from these biofilms. Secondary outcomes include the association between biofilm formation, postoperative infections (such as empyema or wound infection), and the length of hospital stay. This study will be conducted at Ondokuz Mayıs University Faculty of Medicine, Department of Thoracic Surgery, in collaboration with the Department of Microbiology. The findings are expected to contribute to better understanding of optimal drain management and infection prevention strategies after thoracic surgery.

Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial

Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times. Early mobilization has been shown to improve outcomes, but its implementation is often limited by patient fragility and staff resources. This study will test the safety and feasibility of using the Atalante X, a self-balancing exoskeleton, in the Thoracic Surgical ICU at Brigham and Women's Hospital. The exoskeleton is designed to support patients in standing and walking, even if they have limited strength or balance, thereby reducing the physical burden on healthcare staff and increasing patient mobility. Eligible participants are adults recovering from thoracic surgery, who are debilitated (Johns Hopkins Highest Level of Mobility scale ≤ 5). Each participant will undergo up to 2-3 exoskeleton sessions per week for a maximum of 2 weeks. Sessions will be personalized, with progressive standing time and walking depending on patient tolerance. The primary goal is to evaluate the safety of exoskeleton use, measured by adverse events such as skin lesions, cardiovascular instability, or accidental device-related issues. The secondary goals are to evaluate: Feasibility (ability to deliver sessions as planned, duration of standing/walking, level of assistance needed), Usability (patient and staff satisfaction, ease of donning/doffing, staff workload), and Preliminary effectiveness (improvement in mobility scores at discharge). Results will provide early insights into whether robotic exoskeletons can be safely integrated into ICU rehabilitation programs after thoracic surgery.

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner. There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer. Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.

Fissios© and Postoperative Complications (FPoC Trial)

Respiratory physiotherapy as part of a pre-operative physical training program may reduce the risk of developing post-operative complications, improving post-operative results and optimizing physical conditions in patients with a diagnosis of non-small cell lung cancer (NSCLC) undergoing lung resection surgery. During the post-operative period, performing physical exercise has also been proved to increase the capacity for exercise, improve health-related quality of life and reduce the feeling of breathlessness. Fissios App is a tool created by thoracic surgeons, physiotherapists and a specialist doctor in physical medicine and rehabilitation, which has been satisfactorily implemented in thoracic surgery patients; this contains a program of standardized respiratory physiotherapy exercises with a defined time and number of repetitions. The aim is to compare the effectiveness of use of the Fissios App tool as a complement to a peri-operative respiratory physiotherapy program compared to just attendance at a face-to-face peri-operative respiratory physiotherapy program, to reduce the incidence of post-operative complications. It is expected to include 560 patients in the study. Subsequent to evaluation by the investigator and the acceptance of participant to take part in the study, the performing of peri-operative respiratory physiotherapy is prescribed. The participants will be randomly assigned to a study group that uses the tool as a complement to the respiratory physiotherapy program or a control group that should only attend face-to-face respiratory physiotherapy sessions. All the participants should attend face-to-face respiratory physiotherapy classes taught by physiotherapists at the place and time set out in each centre before and after surgery for at least 45 minutes and at least five sessions. Moreover, study group participants may use the Fissios App tool. Investigators should fill in the pre-operative, surgery and post-operative data for each patient on the Fissios Research platform.

Effect of Digital Physiotherapy Practice on Pulmonary Function, Muscle Strength, Quality of Life After Thoracic Surgery

Thoracic surgery is the primary intervention used in the treatment of diseases affecting the lungs, pleura, chest wall, and mediastinum. Postoperative changes occur in both lung functions and clinical symptoms due to the procedure itself and patient-related factors. After thoracic surgery, patients often experience reduced exercise tolerance and impaired respiratory functions, negatively affecting their participation in daily activities, functional levels, and quality of life. In open thoracotomies, the incision site, severed muscles, and the size of the incision can impact upper extremity and trunk functions. The aim of this study is to investigate the effects of physiotherapy applied through digital methods on respiratory functions, respiratory muscle strength, functional capacity, upper extremity muscle strength, and quality of life in patients who have undergone thoracic surgery.

Digital Follow-up Program After Discharge Home Following Thoracic Surgery

The aim of the study is to evaluate whether a digital follow-up program can improve postoperative pain management and quality of life in patients during the first 28 days after discharge home following thoracic surgery, compared to standard follow-up care.

Prognosis of Veno-Venous Extracorporeal Membrane Oxygenation in Emergency Thoracic Surgery

Veno-vneous extracorporeal membrane oxygenation (VV-ECMO) is an established support strategy for acute respiratory failure, but its role in the perioperative management of emergency thoracic surgery remains poorly defined. This retrospective, multicenter, observational study aims to assess the clinical outcomes and prognostic factors in this high-risk population. Patients undergoing emergency thoracic procedures requiring VV-ECMO will be compared to a control cohort of patients treated with VV-ECMO for medical respiratory failure. Data will be collected from two French academic centers (CHU Amiens-Picardie and CHU Dijon).

Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch

Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.

Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients

The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.