Clinical Research Directory

Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation

This is a prospective, randomized, single-center, three-arm, open-label, low-risk medical device clinical study conducted at the Department of Anesthesiology and Reanimation, Trakya University Medical Faculty. The study aims to compare the efficacy, safety, and clinical usability of three laryngoscopy methods for double-lumen endotracheal tube (DLT) intubation in patients undergoing elective thoracic surgery requiring one-lung ventilation: (i) C-MAC hyperangulated (D-blade) videolaryngoscopy, (ii) C-MAC Macintosh blade videolaryngoscopy, and (iii) direct Macintosh laryngoscopy. The primary outcome is the total time to successful DLT placement (in seconds), defined as the interval from the end of mask ventilation to fiberoptic bronchoscopic confirmation of correct tube position. Secondary outcomes include glottic visualization quality (POGO score and Cormack-Lehane grade), intubation difficulty (Intubation Difficulty Scale), number of intubation attempts, need for auxiliary maneuvers, intubation-related complications, malposition rate, and postoperative airway symptoms (sore throat, dysphonia) assessed at 1, 6, and 24 hours postoperatively. Eligible patients are adults (≥18 years), ASA class I-III, scheduled for elective thoracic surgery requiring one-lung ventilation. Patients with anticipated difficult airway, emergency surgery, pregnancy, or prior upper airway surgery are excluded. A total of 180 patients will be enrolled and randomized 1:1:1 into three groups (60 per group) using computer-generated block randomization.

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.

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.

Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer

Postoperative pneumonia (POP) affects 4%-24% of lung cancer surgery patients, increasing mortality, stay, costs and worsening prognosis, especially in older patients. Perioperative immunosuppression and synergistic influenza/pneumococcal infection support perioperative vaccination, which may also induce trained immunity; thoracic surgery data are lacking. This multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial will enroll \~1278 patients aged ≥50 undergoing anatomical lung resection for pulmonary nodules or lung cancer, randomized 1:1 to vaccination or no vaccination, with 180-day follow-up. Randomization uses a computer-generated, site-stratified block sequence, concealed via central IWRS or sealed envelopes. An unblinded team handles screening, randomization and vaccination data; surgeons and assessors are blinded. No site may exceed 50% of enrollment. Vaccination group receives 23-valent pneumococcal polysaccharide and quadrivalent influenza vaccines intramuscularly in separate arms 14-28 days preoperatively. Controls receive no vaccine/placebo, with surgery scheduled 14-28 days after randomization. Concomitant indicated treatments are permitted and recorded. Primary endpoint is POP per modified CDC/NHSN criteria: new/progressive imaging infiltrate (excluding atelectasis, edema, embolism, tumor), plus ≥1 clinical sign (fever \>38 °C, WBC ≤4000 or ≥12,000/mm³, or altered mental status if ≥70 years) and ≥2 respiratory signs. Findings on days 3-5 are excluded unless persistent/worsening. Microbiology is confirmatory, not required.

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.

Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery

This randomized controlled pilot study will compare intermittent positive pressure breathing (IPPB) with incentive spirometry (IS) in adult patients undergoing thoracic surgery. The study aims to evaluate the effects of these two postoperative pulmonary rehabilitation interventions on lung volume recovery, respiratory muscle strength, oxygenation, pulmonary complications, and overall postoperative recovery. Participants will be randomly assigned to either the IPPB group or the IS group. Assessments will be performed before surgery and after the intervention period.

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.

Comparative Study Between Erector Spinae Plane Block Versus Combined Pectoralis and Serratus Interfascial Plane Blocks for Post-operative Analgesia After Thoracic Surgery.

The aim of this study is to evaluate the effect of combined pectoralis II and serratus interfascial plane blocks in comparison with erector spinae plane block on post-operative analgesia after thoracic surgeries.

Continuous Erector Spinae Block Versus Thoracic Epidural Analgesia for the Prevention of Chronic Pain Following Thoracotomy: a Retrospective Study

Post-thoracotomy pain syndrome (PTPS) is a prevalent complication that significantly impacts patients' quality of life, with reported incidence ranging from 25% to 90%. This study evaluated the effectiveness of continuous erector spinae plane (ESP) block compared to thoracic epidural analgesia (TEA), the current gold standard, in preventing PTPS. Our goal was to compare the incidence of PTPS between patients who received ESP block and those who underwent TEA. Additional goals included assessing postoperative pain levels, analgesic consumption, and complications related to the anesthesia techniques.

AirGo™ Respiratory Monitoring in Lung Resection

Patients undergoing lung resection surgery may experience changes in respiratory function during the perioperative period. Current monitoring methods provide important clinical information but are often limited to specific time points and may not allow continuous assessment of ventilation. This study aims to evaluate the feasibility and usefulness of the AirGo™ wearable respiratory monitoring system in patients undergoing anatomical lung resection (lobectomy or segmentectomy). AirGo™ is a non-invasive, CE-marked device that continuously measures respiratory parameters, including minute ventilation and respiratory rate, through a chest-worn sensor. Participants will wear the AirGo™ device before surgery and during the postoperative period. Respiratory parameters collected by AirGo™ will be analyzed at predefined time points and compared with standard clinical monitoring methods routinely used in postoperative care, including pulse oximetry and telemetry. The primary objective is to assess changes in mean minute ventilation from the preoperative period to the first postoperative day. Secondary objectives include evaluating perioperative respiratory trends, patient comfort and compliance with the device, and the agreement between AirGo™ measurements and standard monitoring systems. The results of this study may help determine whether continuous non-invasive respiratory monitoring can improve the assessment and management of patients undergoing lung surgery.

Continuous Lidocaine Infusion Via Closed Chest Drainage Tube for Pain Control After Thoracoscopic Partial Lung Resection

The goal of this clinical trial is to learn about the effects on postoperative analgesia of continuous lidocaine infusion via closed chest drainage tube for patients undergoing thoracoscopic partial lung resection. The main questions it aims to answer are: * To explore whether continuous lidocaine pumping via closed chest drainage tube has good analgesic and anti-inflammatory effects for patients undergoing partial thoracoscopic pneumonectomy. * Whether the multimodal analgesia combined with continuous lidocaine pump can reduce the postoperative application of opioids, reduce the occurrence of postoperative complications, and promote the recovery of postoperative lung function and accelerate recovery. For participants who undergoing the thoracoscopic partial lung resection with postoperative indwelling drainage tube, the epidural tube fixed in the drainage tube is connected to the completed infusion pump (marking the chest drain for analgesia). The comparison group only accept the intravenous analgesia after surgery.

A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures

The purpose of this study is to investigate the effects of the frailty-specific prehabilitation program on functional capacity, frailty, cardiac-specific functional status, serum albumin level, high-sensitivity C-reactive protein (hs-CRP) level, HRQoL, psychological outcomes, major adverse cardiovascular and cerebral events (MACCEs), and hospital readmission rates in cardiac patients. This study tests a home-based prehabilitation program for frail older adults waiting 5+ weeks for heart surgery. Participants, aged 65+ with mild-to-moderate frailty, receive structured preoperative education, protein-rich nutrition advice, relaxation techniques for stress, and exercise training 3 times weekly via home visits, video calls, and self-practice. A control group gets sham light stretching plus usual care.

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.

Post-Operative Physical Activity Monitoring: Algorithm Performance and Clinical Outcomes

The goal of this observational study is to validate physical activity algorithms in post-operative populations through raw accelerometer data collection using the ADI Study Watch 4.5 while in an in-patient setting. The secondary objective of the study is to collect skin temperature, photoplethysmography \[PPG\], Bioimpedance Analysis \[BIA\], heart rate \[HR\], SpO2, and electrodermal activity \[EDA\] using the ADI Study Watch 4.5. The main questions it aims to answer are: * Can a wearable physical activity monitoring device assess patients\' activity levels with higher accuracy and precision compared to traditional physical activity monitoring methods during the post-operative period? * Do wearable devices placed on different body regions perform similarly in tracking physical activity during the post-operative period? * Do post-operative physical activity monitoring algorithms improve patient compliance, accelerate recovery, and reduce hospital stay duration? * Analysis of the activity tracking performance of a consumer device (Apple Watch) in patients after cardiac and thoracic surgery.

Wireless Wearable Home Prehabilitation for Older Adults With NSCLC

This randomized controlled trial evaluates the efficacy and safety of a home-based prehabilitation program using wireless wearable monitoring devices in older patients (aged 65-85 years) with non-small cell lung cancer scheduled for curative lung resection. Participants are randomized 1:1 to either the intervention group, receiving a personalized exercise regimen (aerobic, resistance, and inspiratory muscle training) with continuous remote monitoring of steps, heart rate, and SpO₂ from 2-4 weeks preoperatively through 90 days postoperatively, or the control group receiving standard perioperative care. The primary endpoint is the between-group difference in FEV₁% predicted at 90 days post-surgery, adjusted for baseline. Secondary endpoints include functional capacity (6-minute walk distance), daily physical activity, hypoxemic burden (time with SpO₂\<90%, nocturnal oxygen desaturation index), patient-reported outcomes (EORTC QLQ-C30/LC13, mMRC), postoperative complications, readmission rates, days alive and at home, and safety outcomes. The target sample size is 198 participants enrolled at West China Hospital of Sichuan University. Anticipated risks include exercise-related musculoskeletal strain, fatigue, and transient cardiopulmonary symptoms, as well as mild skin reactions from devices, all managed through individualized exercise prescriptions, remote safety thresholds, and a graded response protocol.

Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC). Eligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up. The primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ \<90% time burden, quality of life (EORTC QLQ-C30/LC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes. A total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.

Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial designed to evaluate whether a digital rehabilitation program integrated with wireless wearable continuous monitoring devices can shorten the time to functional recovery in patients with multiple primary non-small cell lung cancer (MPLC) who undergo sequential (two-stage) curative-intent resection. Eligible participants will be randomly assigned to either the intervention group or the control group. Both groups will receive standard enhanced recovery after surgery (ERAS) care. In addition, the intervention group will receive continuous vital sign monitoring (using a wearable patch during hospitalization and a wrist-worn device after discharge), personalized exercise prescriptions with daily step targets, and high-frequency electronic patient-reported outcome (ePRO) follow-up with threshold-triggered response. The control group will receive standard intermittent vital sign monitoring and conventional rehabilitation education. The primary endpoint is the time from the first surgery to attainment of functional recovery criteria sufficient for second-stage surgery readiness (assessed by a composite of step count recovery, functional interference score combined with 6-minute walk distance, or multidisciplinary team determination). Secondary endpoints include pulmonary function recovery (FEV1%, FVC%, DLCO% at 3 months), physical activity (daily steps, moderate-to-vigorous physical activity, 6-minute walk distance), symptom burden and quality of life (EORTC QLQ-C30/LC13, PROMIS), 30- and 90-day complication and readmission rates, second-surgery-related outcomes, adherence, safety, and healthcare resource utilization. A total of 222 participants (111 per group) will be enrolled. The study will be conducted at West China Hospital of Sichuan University from June 2026 to October 2027. The findings are expected to provide high-quality evidence on the clinical utility of wearable-integrated digital rehabilitation in the perioperative management of MPLC patients undergoing sequential resection.

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.

Comparison of Liposomal Bupivacaine Paravertebral Nerve Block Versus Intercostal Nerve Block on Postoperative Glycemic Variability in Patients Undergoing Minimally Invasive Pulmonary Resection: A Randomized Controlled Non-Inferiority Trial

In this randomized controlled non-inferiority trial, we will test whether liposomal bupivacaine intercostal nerve block is non-inferior to paravertebral nerve block for the coefficient of variation (CV) of glucose during the 0- to 48-hour postoperative period, using a non-inferiority margin of Δ = 0.025 for the absolute CV difference. We will also compare the two blocks regarding their effects on postoperative glucose, autonomic function, stress, insulin resistance, acute pain, recovery quality, procedure duration, complications, and hemodynamic stability.

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

Effects of Permissive Hypercapnia During Lung Surgery on Inflammatory Biomarkers in Serum and Bronchoalveolar Lavage Fluid

The primary objective was to evaluate the effects of permissive hypercapnia on inflammatory biomarkers in bronchoalveolar lavage fluid and serum during one-lung ventilation. The secondary objective was to assess the influence of different ventilation modes on these inflammatory responses. Methods: Forty patients undergoing elective lung surgery requiring OLV were prospectively enrolled an allocated to either a normocapnic (n=20) or hypercapnic group group (n=20). BAL concentrations of TNF-α, IL-1β, IL-6, and IL-8 were measured before and after intervention. Serum IL-6, C-reactive protein (CRP), and leukocyte counts were also assessed. Patients were further stratified according to ventilation mode (PC or VC). Outcome measures: Primary outcome: change of bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α , IL-1β, IL-6, and IL-8) as well as in serum (IL-6, CRP, and WBC) between the normocapnic and hypercapnic groups during one-lung ventilation. Secondary outcome: whether the inflammatory response differed according to the ventilation mode (pressure-controlled versus volume-controlled ventilation).

Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery

Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.

Major Vascular Injuries in Elective Thoracic Surgery: A 10-Year Single-Center Experience

This study retrospectively examines major vascular injuries that occurred during elective thoracic surgeries over a 10-year period at a single tertiary care center. Although these injuries are rare, they can lead to life-threatening complications. The study aims to determine how often these injuries happen, what causes them, and how they are managed during surgery. It also evaluates the role of preoperative imaging and planning, including cardiovascular surgery team involvement, in preventing or managing these events. The findings are intended to help improve surgical safety and guide future preventive strategies.

VIRTUAL REALITY TRAINING AFTER THORACIC SURGERY

This study aims to investigate the effects of virtual reality-based exercise training after thoracic surgery. Participants undergoing lung resection surgery will be assigned to either a virtual reality exercise training group or a control group receiving standard care. Physical function, pulmonary function, exercise capacity, dyspnea, anxiety, depression, and quality of life will be evaluated before and after the intervention. The findings may help determine whether virtual reality-assisted exercise training improves postoperative recovery in patients undergoing thoracic surgery.