Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Infections

Rare Diseases

Lung Neoplasms

Lung Diseases

Fibrosis

Pneumonia

Respiratory Insufficiency

Lung Diseases, Interstitial

Pulmonary Fibrosis

Respiratory Tract Diseases

Respiration Disorders

Acute Graft Versus Host Disease

All Drugs and Chemicals

Dimercaprol

Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask.

Administration of high flows (up to 60 L/min) of air/oxygen admixtures, heated (at temperatures ranging from 31 to 37°C) and fully humidified (up to 44 mg H2O/L), providing an inspired oxygen fraction ranging from 21 to 100%

application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet

application of a PEEP by means of a mask or helmet, with an inspiratory pressure support triggered by the patient and delivered by a ventilator and through interfaces such as mask or helmet

application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube

Patients will undergo to the bronchial endoscopy procedure required for their clinical condition: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS).

Bronchoscopy

Federico Longhini, MD

The current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack.

The goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings.

Investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study.

Investigators will record the following data:

* Patient's baseline data.
* Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded.
* Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation.
* Sedation
* Intra-procedural vital parameters
* Occurrence of adverse events: desaturation (i.e. SpO2\< 90% for at least 10 seconds), severe desaturation (i.e. SpO2\< 80%), need for procedure interruption, hypotensive (systolic blood pressure \<90 mmHg) or hypertensive (systolic blood pressure \>140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation).
* Post-procedural vital parameters (15 minutes after the procedure).
* Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: The Oxy-FOB STUDY

Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator

The type of oxygenation strategy (standard oxygen therapy, high flow nasal cannula, continuous positive airway pressure, non invasive ventilation or invasive mechanical ventilation) adopted during the bronchoscopy will be recorded.

The type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded.

The lowest peripheral oxygen saturation recorded during the procedure

The lowest heart rate recorded during the procedure

The highest heart rate recorded during the procedure

The lowest systolic blood pressure recorded during the procedure

The highest systolic blood pressure recorded during the procedure

The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure

Occurrence of peripheral oxygen saturation \< 90% for at least 10 seconds

Occurrence of peripheral oxygen saturation \< 80%

Occurrence of systolic blood pressure \<90 mmHg

Occurrence of systolic blood pressure \>140 mmHg

Need to escalate the oxygenation/ventilation support from from standard oxygen therapy (lowest support) to High Flow Nasal Cannula, Continuous Positive Airway Pressure, Non Invasive Ventilation or invasive Mechanical Ventilation (highest grade of support)

Need for admission to ward or intensive care unit after the endoscopy completion

University Magna Graecia

Director of the Intensive Care and Anesthesia Department

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Digestive System Diseases

Pleural Effusion

Emergencies

Pulmonary Atelectasis

Multiple Pulmonary Nodules

Cardiomegaly

Calcinosis

Pneumothorax

Pneumoperitoneum

Solitary Pulmonary Nodule

Pleural Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Peritoneal Diseases

Gastrointestinal Diseases

Heart Diseases

Hypertrophy

Pathological Conditions, Anatomical

Chronic Graft Versus Host Disease

Reader Selection: 30 readers will be selected from the following five clinical specialty groups:

* emergency medicine (ED)
* adult intensive care (ICU)
* adult general medicine (AGM)
* radiographers (Rad)
* general radiologists

Each specialty group consists of 6 members of ranked seniority. For the physicians this consists of:

* Two 'Juniors' (Foundation Year 1 - Specialty Training 2 years)
* Two 'Middle Grades' (Registrar from Specialty Training 3 to 6 years)
* Two Consultants

For the radiographers, this consists of:

* Two 'Junior/Newly qualified radiographers' (up to 18 months experience post qualification)
* Two 'Mid-experience radiographers' (approx. 3 years' experience)
* Two 'Reporting radiographers' (5+ years' experience)

Two consultant thoracic radiologists. A third senior thoracic radiologist's opinion (\>20 years experience) will undertake arbitration.

The reading will be done remotely via the Report and Image Quality Control site (www.RAIQC.com), an online platform allowing medical imaging viewing and reporting. Participants can work from any location, but the work must be done from a computer with internet access. For avoidance of doubt, the work cannot be performed from a phone or tablet.

The project is divided into two phases and participants are required to complete both phases. The estimated total involvement in the project is up to 20-24 hours.

Phase 1: Time allowed: 2 weeks

- Review 500 chest X-rays and express a clinical opinion through a structured reporting template (multiple choice, no open text required).

Rest/washout period of 2 weeks.

Phase 2 - Time allowed: 2 weeks

- Review 500 chest X-rays together with an AI report for each case and express your clinical opinion through the same structured reporting template used in Phase A.

Cases reading

Two consultant thoracic radiologists will independently review the images to establish the 'ground truth' findings on the CXRs, where a consensus is reached this will then be used as the reference standard. In the case of disagreement, a third senior thoracic radiologist's opinion (\>20 years experience) will undertake arbitration. A difficulty score will be assigned to each abnormality by the ground truthers using a 4-point Likert scale (1 being easy/obvious to 4 being hard/poorly visualised).

Ground truthing

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838).

The Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the diagnostic accuracy, speed, and confidence of a varied group of healthcare professionals. The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two United Kingdom (UK) hospital trusts. Two fellowship trained thoracic radiologists will independently review all studies to establish the ground truth reference standard. The Lunit INSIGHT CXR tool will be used to analyze each CXR, and its performance will be measured against the expert readers. The study will evaluate the utility of the algorithm in improving reader accuracy and confidence as measured by sensitivity, specificity, positive predictive value, and negative predictive value. The study will measure the performance of the algorithm against ten abnormal findings, including pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion, and pneumoperitoneum. The study will involve readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR. The study will provide evidence on the impact of AI algorithms in assisting healthcare professionals such as emergency medicine and general medicine physicians who regularly review images in their daily practice.

AI Assisted Detection of Chest X-Rays

Utility of an AI-based CXR Interpretation Tool in Assisting Diagnostic Accuracy, Speed, and Confidence of Healthcare Professionals: a Study Using 500 Retrospectively Collected Inpatient and Emergency Department CXRs From Two UK Hospital Trusts

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine sensitivity.

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine specificity.

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard. Continuous probability score from the algorithm will be utilized for the ROC analyses, while binary classification results with a predefined operating cut-off will be used for evaluation of sensitivity, specificity, positive predictive value, and negative predictive value.

The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader.

Mean time taken to review a scan, with vs without AI assistance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy	NCT05681962	Acute Respirato... Pneumonia Lung Cancer Fibrosis Lung Interstitial Lu...	Bronchoscopy	18 Years -	University Magna Graecia
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy	NCT05681962	Acute Respirato... Pneumonia Lung Cancer Fibrosis Lung Interstitial Lu...	Bronchoscopy	18 Years -	University Magna Graecia
AI Assisted Detection of Chest X-Rays	NCT06075836	Pulmonary Nodul... Pulmonary Nodul... Pulmonary Conso... Pneumothorax Pneumothorax; A... Atelectasis Pulmonary Calci... Cardiomegaly Fibrosis Lung Pleural Effusio... Pleural Effusio... Pneumoperitoneu...	Cases reading Ground truthing	-	Oxford University Hospitals NHS Trust
AI Assisted Detection of Chest X-Rays	NCT06075836	Pulmonary Nodul... Pulmonary Nodul... Pulmonary Conso... Pneumothorax Pneumothorax; A... Atelectasis Pulmonary Calci... Cardiomegaly Fibrosis Lung Pleural Effusio... Pleural Effusio... Pneumoperitoneu...	Cases reading Ground truthing	-	Oxford University Hospitals NHS Trust

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