Clinical Research Directory

Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.

The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications

Study Background and Purpose As society ages, an increasing number of elderly patients undergo surgery. Following surgery, particularly abdominal procedures, patients are susceptible to lung-related issues such as atelectasis (lung collapse) and infection, collectively known as Postoperative Pulmonary Complications (PPCs). These complications are a major factor affecting the recovery of elderly patients. One method of general anesthesia is called Total Intravenous Anesthesia (TIVA). This study aims to investigate whether using an automated lung recruitment function, a smart feature available on modern anesthesia machines, can help protect lung function and reduce complications in elderly patients undergoing laparoscopic surgery under TIVA. The goal is to identify safer and more effective methods for anesthesia care. Study Design This is a clinical research study. Eligible elderly patients who provide consent will be randomly assigned to one of two groups: Study Group: The automated lung recruitment function on the anesthesia machine will be used to manage breathing during surgery. Control Group: Current standard methods for breathing management will be used during surgery. The primary goal is to observe and compare the blood oxygenation level 30 minutes after surgery (a key indicator of lung function) between the two groups. The investigators will also record the occurrence of any lung-related complications within the first 3 days after surgery. What Will Participants Do? If participants agree to participate, they will be asked to: Sign an informed consent form. Undergo some pre-operative assessments arranged by the research team. Receive the corresponding breathing management method during surgery, as determined by random assignment. Allow the research team to collect relevant medical data after surgery (e.g., blood gas analysis results, medical records). All data will be kept strictly confidential. Participation does not involve any additional invasive procedures. All medical care and monitoring will adhere to the standard safety protocols required for the surgery, and may even be more meticulous. Potential Benefits and Risks of the Study Potential Benefits: Direct Benefit: Participants will receive more precise monitoring and care for their respiratory function during and after surgery. Societal Value: Data from their participation will contribute to developing better anesthesia strategies for future elderly patients, potentially improving their recovery outcomes. Potential Risks and Protections: The study intervention is integrated into standard anesthesia. The main risks are associated with routine anesthesia and surgery itself (e.g., temporary blood pressure fluctuations, low oxygen levels). These risks are possible in any similar surgical procedure. The study will be conducted by experienced anesthesiologists with continuous, close monitoring. Comprehensive emergency plans are in place to ensure participant safety. Participants have the right to withdraw from the study at any time, for any reason, without affecting their eligibility for any future standard medical care. All personal information and study data will be kept strictly confidential. Data will be analyzed using coded identifiers only. Any published results will not contain information that could reveal the identity of participants.

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure. The main question it aims to answer is (study hypotheses): Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.

Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)

This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards/ requirements.

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days. The primary outcome is the day 4 oxygenation index assessed as a continuous measure.

PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients

The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery