Respiratory Stabilization in Chronic Acidosis Before Bronchofiberoscopy & Non-Invasive Ventilation Effectivenes
Launched by MEDICAL UNIVERSITY OF SILESIA · May 5, 2025
Trial Information
Current as of July 28, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the best ways to support patients with chronic respiratory acidosis during a procedure called bronchofiberoscopy (FOB), which helps doctors diagnose or treat lung conditions. The study will look at patients with specific breathing issues and compare three types of respiratory support: passive oxygen therapy, non-invasive ventilation (NIV), and high flow nasal cannula (HFNC). The goal is to find out which method helps patients breathe better and experience fewer complications during and after the procedure.
To participate in this trial, you need to be at least 18 years old and have a medical reason for needing a bronchofiberoscopy, such as suspected lung cancer or other lung conditions. You should also have certain blood gas test results that indicate a respiratory acidosis condition. Participants will undergo blood tests before and after the procedure to monitor their breathing and overall health. Throughout the trial, the medical team will closely track your vital signs to ensure your safety and comfort. This study aims to improve the care and support available for patients with breathing difficulties, leading to quicker diagnoses and more comfortable procedures.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 1. Patient ≥ 18 years of age with indications for diagnostic bronchoscopy:
- • ◦ Diagnostic test: suspected lung cancer, suspected sarcoidosis, mediastinal lymphadenopathy,
- • 2. Patient who signed a written informed consent to participate in the study,
- • 3. pCO2 \> 45 mmHg and/or HCO3- \> 27 mmol/l but pH ≥ 7.35 in a blood gas test performed immediately before qualification for bronchoscopy.
- Exclusion Criteria:
- • 1. Lack of written informed consent of the subject to participate in the research project,
- • 2. Coronary artery disease CCS III/IV,
- • 3. Hemodynamic failure, use of pressor amines, myocardial infarction in the last 2 weeks without PCI treatment, unstable angina pectoris, severe arrhythmias - especially ventricular,
- • 4. Pneumothorax not secured with drainage,
- • 5. Platelet count \<20,000/µl, if platelets are not transfused immediately before/during the procedure,
- • 6. INR \> 1.5xULN or APTT \>36 s.1.5xULN, in the case of diagnostic FOB \[16\],
- • 7. Anemia: hemoglobin (Hb) level \<6 g/dl or 6-10 g/dl if the physician prescribes a blood transfu-sion,
- • 8. Patients who were intubated before randomization.
About Medical University Of Silesia
The Medical University of Silesia is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. Located in Poland, the university is renowned for its commitment to medical education, interdisciplinary collaboration, and the development of new therapeutic approaches. With a focus on translating scientific discoveries into practical applications, the Medical University of Silesia sponsors a range of clinical trials aimed at improving patient outcomes and enhancing the understanding of various medical conditions. Through its rigorous ethical standards and robust research infrastructure, the university plays a pivotal role in shaping the future of medicine both regionally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Szymon Skoczyński, PhD, professor of university
Principal Investigator
Department of Lung Diseases and Tuberculosis, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported