Clinical Research Directory

Collection of Lung Fluid and Tissue Samples for Research

This study will collect fluid and tissue specimens from the lungs and nose of healthy people and people with a history of lung infections. The specimens will be examined for differences between the two groups that may be associated with susceptibility to certain infections. Healthy normal volunteers and people with a history of lung infections between 18 and 75 years of age who are followed at NIH may be eligible for this study. Participants undergo the following procedures: Medical history and physical examination. Blood and urine tests. Electrocardiogram (ECG) and chest x-ray. Treadmill exercise stress test (for people over 45 years old with a history of chest pain or ECG abnormalities). Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Fluid collection during the bronchoscopy using one of the following methods: * Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung and immediately suctioned out, washing off cells lining the airways. * Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the bronchoscope and a small area of the airway tissue is gently brushed. The brush is withdrawn with some tissue adhering to it. * Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and about 1 to 2 millimeters of tissue is removed. * Nasal scrape: A small device is used to scrape along the inside of the nose to collect some cells. * Sputum induction * Exhaled breath condensate to obtain specimens for in vitro investigations and comparisons of both the cellular and acellular components. * Nasal nitric oxide production * Nasal potential difference * Exhaled aerosol mask sample collection * Cough aerosol collection * Exhaled particle collection * Lung Clearance Index (LCI)...

Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy

The goal of this observational study is to learn whether dexmedetomidine nasal spray is associated with a lower risk of postoperative sore throat in adult patients who underwent bronchoscopy under general anesthesia. The main questions it aims to answer are: Is dexmedetomidine nasal spray associated with a lower incidence of sore throat after bronchoscopy? What is the average treatment effect of dexmedetomidine nasal spray on postoperative sore throat? Does the treatment effect differ across patient subgroups (treatment effect heterogeneity)? Researchers will compare patients who received dexmedetomidine nasal spray with patients who did not receive it to see if the nasal spray is associated with less postoperative sore throat, and whether some patients benefit more than others. This is a two-center retrospective cohort study. No participants will be asked to do anything, and no interventions will be given. Existing medical records of patients who underwent bronchoscopy will be analyzed. The analysis follows a target trial emulation framework, which mimics a randomized trial using existing data, and uses statistical and machine learning methods to account for differences between patient groups.

Chewing Gum and Cold Gargle on Post-Bronchoscopy Symptoms

This study aims to evaluate the effects of chewing gum and gargling with cold water on common post-bronchoscopy symptoms, such as sore throat and difficulty swallowing (dysphagia). Bronchoscopy is a procedure that can cause temporary throat discomfort. In this randomized controlled trial, patients will be divided into groups to receive either chewing gum, cold water gargle, or standard care. The researchers will then measure and compare patient satisfaction levels and the severity of throat symptoms to determine if these simple interventions can improve patient comfort after the procedure.

Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients

The goal of this clinical trial is to learn if patients feel more comfortable while being placed on contemporary fasting principle than on conventional fasting time during flexible bronchoscopy. The main questions it aims to answer are: To compare the thirty levels between patients with conventional fasting time (≥ 8 hours) and those with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) during flexible bronchoscopy To compare the levels of mucosal dryness between two groups of patients during flexible bronchoscopy To compare the levels of hunger between two groups of patients during flexible bronchoscopy To compare the levels of tiredness between two groups of patients during flexible bronchoscopy To compare the levels of fatigue between two groups of patients during flexible bronchoscopy To compare the levels of nausea/vomiting between two groups of patients during flexible bronchoscopy Participants will: Being placed on fasting either using conventional fasting time (≥ 8 hours) or with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) Being asked to respond to questions regarding thirsty, mucosal dryness, hunger, tiredness, fatigue, and nausea/vomiting in a visual analogue scale of 0 to 10

Ciprofol Versus Propofol With Low-Dose Sufentanil for Painless Bronchoscopy

Bronchoscopy may cause coughing, discomfort, body movement, and changes in breathing or blood pressure. Propofol is commonly used for sedation during bronchoscopy, but it may cause respiratory depression, circulatory depression, and injection pain. Ciprofol is another intravenous sedative that may provide effective sedation with fewer adverse effects. This study compared ciprofol combined with low-dose sufentanil with propofol combined with low-dose sufentanil in adults undergoing bronchoscopy under intravenous sedation. A total of 100 adults aged 35 to 65 years with no or mild systemic disease were randomly assigned in a 1:1 ratio to two treatment groups. Participants in one group received ciprofol and low-dose sufentanil, while participants in the other group received propofol and low-dose sufentanil. The study evaluated the amount of sedative used, adverse events, sedation onset time, recovery time, recovery quality, blood pressure, heart rate, oxygen saturation, and the overall effectiveness of anesthesia.

Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol

In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.

Randomized Controlled Trial of Multi-Patient CT-Derived Digital Twin Anatomical Variability Training to Shorten the Clinical Learning Curve for Bronchoscopy

This study aims to determine whether multi-patient CT-derived digital twin anatomical variability training can shorten the early clinical learning curve of novice bronchoscopists compared with conventional anatomically uniform bronchoscopy simulation training.

Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)

Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE. This study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate/not appropriate) and malignancy suspicion (benign/malignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure. The study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency. The AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.

Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection

Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.

Preprocedural Video Education for Bronchoscopy Anxiety

The goal of this clinical trial is to learn whether preprocedural video education can reduce anxiety in adult patients who are scheduled to undergo bronchoscopy under general anesthesia. It will compare video-based education with standard verbal education. The main questions it aims to answer are: Does video education reduce preprocedural anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS), in patients undergoing bronchoscopy under general anesthesia? Researchers will compare patients who receive audiovisual education with those who receive standard verbal education to see whether video education provides greater anxiety reduction before bronchoscopy under general anesthesia. Participants will: 1. Complete an APAIS questionnaire before receiving preprocedural education 2. Receive either video-based education using a tablet or standard verbal education with a question-and-answer session 3. Complete another APAIS questionnaire immediately after the education session

Safety of Bronchoscopy in Patients With Interstitial Lung Disease

Bronchoscopy is an essential technique, routinely used in the differential diagnosis workup of many Interstitial Lung Diseases (ILDs) and in referral centres is a common procedure. Bronchoalveolar lavage (BAL), bronchial and transbronchial biopsies with forceps and cryoprobes, and lymph node sampling with endosonography represent the most used sampling techniques in these patients. However, patients with ILDs refer to medical attention in a wide range of clinical conditions from mild functional impairment, with absent or few respiratory symptoms, to severe lung involvement with low exercise tolerance and/or chronic respiratory failure. In these patients, a balance between benefits and risk, i.e. to the safety and diagnostic utility of bronchoscopy should be always carefully evaluated. Moreover, there is a wide variability in adverse events entity and frequency depending by procedures performed during bronchoscopy. Despite its crucial utility, only few data are available in the literature on the safety of bronchoscopy in patients with ILDs and limited data on the utility and safety of this sampling technique are present in patients with AE-ILDs. The primary aim of this study is to assess the overall rate of complications occurring within 24 hours after bronchoscopy. Study rate and type of complications occurring during the endoscopic procedure, within 30 days after bronchoscopy, in patients with AE-ILDs, among fibrotic Vs non-fibrotic ILD, and according to each employed sampling technique will be also recorded.

AI-Driven Autonomous Registration in Robotic Bronchoscopy

This study aims to evaluate the feasibility and safety of an artificial intelligence (AI)-driven autonomous registration technology in robotic navigational bronchoscopy. A total of 20 patients with pulmonary nodules requiring localization will be enrolled. The Langhe Bronchoscopy Robot System equipped with AI-based autonomous registration software will be used. Primary outcomes include the success rate of autonomous registration and the rate of manual intervention during the process. Secondary outcomes encompass registration time, complication rates, and nodule localization success.

Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea

What is this study about? This study tests a new robotic technology to take tissue samples from lung nodules (small spots in the lungs). Some lung nodules are cancer, but doctors need a tissue sample to know for sure. What is the problem? Current methods to get tissue from lung nodules only work about 7 out of 10 times. When they don't work, doctors may need riskier procedures. What is the new technology? The new technology is called robotic bronchoscopy (ssRAB). It uses a robot with special sensors to guide a thin tube more accurately to lung nodules than current methods. Who can join? Adults aged 19 or older who have lung nodules that need tissue sampling and are healthy enough for the procedure. What happens? Participants will have the robotic procedure while asleep under anesthesia. The robot guides a thin tube to the lung nodule to take a small tissue sample. Participants are watched for problems and followed for 6 months. What are the risks and benefits? The new technology may be more accurate and safer than current methods. The main risks are small chance of lung collapse or bleeding, similar to regular procedures. Why is this important? This study will show if the new robotic technology works well and is safe in Korea. If successful, it could help diagnose lung cancer earlier and more accurately. This study will include 100 people at Ulsan University Hospital in Korea.

The LUCENT Study - LUng Lesion Assessment Via BF-UCP190F for Central and Extended Nodal Targeting

The Olympus BF-UCP190F bronchoscope combines the reach of a thinner bronchoscope with the benefit of real-time ultrasound, enabling direct lesion visualization and sampling deeper into the lung. Following promising first-in-human data, the LUCENT study aims to evaluate the utility feasibility, effectiveness and safety of this device in a multicenter setting, generating real-world evidence to inform broader adoption in global markets.

Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

Airway management problems are key drivers for anesthesia-related adverse events. Awake tracheal intubation using flexible bronchoscopes with preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anesthesia, intensive care and emergency medicine. However, a prospective developed classification for this type of airway management is lacking. Due to the absence of a specifically tailored, validated classification for awake intubation with flexible bronchoscopes, many airway operators and institutions use classification tools that were originally developed for direct laryngoscopy, such as the percentage of glottic opening (POGO) score or Cormack-Lehane classification, although their diagnostic performance for the classification of ATI:FB is unknown. This prospective model development and validation study aims to develop two multivariable prediction models: a diagnostic prediction model to classify difficult ATI:FB after ATI:FB has been performed and a second prognostic prediction model to predict the risk for difficult ATI:FB before ATI:FB is performed. An additional aim is to develop a machine learning algorithm to evaluate ATI:FB.

Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy

The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are: * Is the recovery of spontaneous breathing within 15 minutes after drug discontinuation with mivacurium chloride non-inferior to succinylcholine? * How do mivacurium chloride and succinylcholine compare in terms of intraoperative hemodynamics and post-operative recovery and comfort? Researchers will compare the mivacurium chloride group and the succinylcholine group to observe if mivacurium chloride can provide similar or better recovery effects compared to succinylcholine. Participants will: * Receive either mivacurium chloride (0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion) or succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion) as a muscle relaxant during bronchoscopy. * Have their vital signs, including blood pressure, oxygen saturation, and heart rate, monitored at multiple time points during the procedure. * Be assessed post-procedure for spontaneous breathing recovery, consciousness recovery, and time to laryngeal mask airway (LMA) removal, as well as overall comfort and satisfaction.

FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department

Non-Profit Prospective Observational Pilot Study The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval. In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\' data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy. This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.