Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Digestive System Diseases

Rare Diseases

Pleural Effusion

Emergencies

Fibrosis

Pulmonary Atelectasis

Multiple Pulmonary Nodules

Cardiomegaly

Calcinosis

Pneumothorax

Pneumoperitoneum

Pulmonary Fibrosis

Solitary Pulmonary Nodule

Pleural Diseases

Respiratory Tract Diseases

Lung Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Peritoneal Diseases

Gastrointestinal Diseases

Lung Diseases, Interstitial

Heart Diseases

Hypertrophy

Pathological Conditions, Anatomical

Chronic Graft Versus Host Disease

Acute 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.

Oxford University Hospitals NHS Trust

Primary Investigator

Pleural Effusion, Malignant

Pleural Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Anesthetics

Fentanyl

Dexmedetomidine

Midazolam

Dexmedetomidine infusion for pleuroscopy sedation. Rescue drugs will be midazolam for inadequate sedation and fentanyl for pain control

Midazolam for sedation and fentanyl for pain will be used for pleuroscopy monitored anesthesia care

The primary objective of this prospective trial will be to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic medical thoracoscopy/pleuroscopy for a pleural effusion compared to conventional conscious sedation/monitored anesthesia care (MAC) with midazolam. The secondary endpoint of the study will be to also assess the effects of dexmedetomidine administration on respiratory mechanics and postprocedural complications

The study will be conducted at the Department of Anesthesiology and Pain Management in collaboration with the Department of Thoracic Surgery at the Attikon University Hospital, Athens.

The trial has received approval by the Attikon University Hospital's Scientific \& Bioethics Committee and written informed consent will be obtained from all patients enrolled in the study.

Sample Size Calculation: A total of 60 patients will be assigned on a 1 to 1 basis to avoid bias to either a "DEX = dexmedetomidine" (n=30) or a "MIDAZOLAM/FENTANYL" group (n=30). To determine the required sample sizes quoted above, the statistical G-power calculator developed by Faul, Erdfelder, Lang, and Buchner was used. Values used to calculate the effect size (e=0.9326031) are based on results previously reported in the literature. For a study power of 90% with an alpha value of 0.05, a total of 26 patients in each group will need to be enrolled. Factoring in possible losses this number was rounded up to 30 patients per group.

Main Measurements Performance \& Methods: Patients will initially be assessed with spirometry and arterial blood gas (ABG) analysis prior to the medical thoracoscopy/pleuroscopy to determine their baseline values of Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Partial arterial Pressure of Oxygen/ Fraction of Inspiratory Oxygen (PaO2/FiO2) ratio respectively. Intra-operatively repeat ABG analysis will be performed at 30 minutes following the start of administration of the study drug. Subsequent to their medical thoracoscopy/pleuroscopy procedure study subjects will remain in the Post Anesthesia Care Unit (PACU) for a minimum of 1 hour following the discontinuation of the study drug. Repeated ABG analysis and spirometry will be carried out at that 1 hour to assess improvement over the pre-operative values. The administration of the spirometry exam will be by the same pulmonologist using the same spirometer device so as to minimize inter-observer variability. Arterial blood gas measurements will also be performed in the same analysis device.

Protocol for Sedation \& Analgesia: Dexmedetomidine (DEX) group: Initial loading dose of dexmedetomidine will be 1.0 μg/kg of dexmedetomidine administered over 10 minutes. Fifteen minutes after starting the study drug administration, patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2. MIDAZOLAM/FENTANYL group: Patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2 All subjects will receive local anesthesia prior to the commencement of the "open" trocar insertion technique performed by the thoracic surgeon at the point of introduction of the rigid trocar in the pleural cavity with a combination of lidocaine 1.5% and ropivacaine 0.75%. If a patient is not adequately sedated, rescue midazolam will be administered as single IV boluses of 0.5 mg, which will be repeated as needed to achieve an OAA/S score of ≤3. Intravenous fentanyl, 25 μg boluses which can be repeated as necessary, will be given if a patient expresses a pain score of ≥3 during the study drugs infusion and ≥4 in the PACU on a Verbal scale of 0-10 (0 = no pain, 10 = worst pain), or if the anesthetist determines the presence of pain when verbal communication is not possible. Blood gas analysis will be obtained at 30' and 60' minutes intraoperatively. The dexmedetomidine infusion will be discontinued after wound closure.

At any time, if clinically indicated, the patient will be converted to an alternative sedative or anesthetic therapy and the study will be discontinued. OAA/S scores and all standard vital signs will be obtained every 5 min throughout the study drug infusion and before the administration of any rescue midazolam.

The time to reach OAA/S =5 from the end of infusion will be recorded. Other data recorded at the end of surgery will include total fentanyl and midazolam used intraoperatively, crystalloid infusion in litres, total mcg of the study drug (provided a \[dex\] = 4 mcg/ml) and postoperative Visual Analogue Scale (VAS) pain score. If VAS\>3 acetaminophen 1 g will be administered. The patient's monitoring will be continued in the post-anesthesia care unit (PACU) with vital signs been recorded every 5 minutes for the first 15 minutes, then every 15 minutes for the next 45 minutes. Blood gas analysis will be obtained every 30' until discharge from the PACU. At 24 hours from the end of surgery, a spirometry will be performed. Patient satisfaction and surgeon satisfaction score will also be registered (4-point scale - 0 min to 3 max). Patients will be discharged from the PACU when their OAA/S score =5.

Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy

The Effect on Respiratory Function of Monitored Anesthesia Care With Dexmedetomidine in Patients Undergoing Diagnostic or Therapeutic Pleuroscopy

This 5 point Scale is used to assess level of sedation during the procedure (5- Responds readily to name spoken in normal tone, 4-Lethargic response to name spoken in normal tone, 3-Responds only after name is called loudly and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking)

incidence of bradycardia (HR \<45 beats/ min) during procedure

incidence of hypotension (MAP\<65 mmHg) during procedure

incidence of hypoxemia (SaO2\< 92%) during procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy	NCT03597828	Pleural Effusio... Pleural Effusio... Pleural Disease...		18 Years - 100 Years	Attikon Hospital
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

Spots Global Cancer Trial Database for pleural effusions, chronic