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Search / Trial NCT06970041

To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure).

Launched by MEDICAL UNIVERSITY OF SILESIA · May 5, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Bronchofiberoscopy (Fob) High Flow Nasal Cannula (Hnfc) Non Invasive Ventilation (Niv) Passive Oxygen Therapy Type 2 Respiratory Failure Exacerbation Of Chronic Respiratory Acidosis Invasive Mechanical Ventilation (Imv)

ClinConnect Summary

This clinical trial is studying different methods of providing breathing support for patients with severe respiratory failure who need a procedure called bronchofiberoscopy (FOB). FOB is a safe and minimally invasive way to look inside the lungs and treat problems. However, it can make breathing harder, so the researchers want to find out which breathing support—such as passive oxygen therapy, non-invasive ventilation (NIV), high flow nasal cannula (HFNC), or invasive mechanical ventilation (IMV)—works best to help patients during and after this procedure. They will monitor patients closely before, during, and after FOB to see which method leads to fewer complications and a better overall experience.

To participate in this trial, patients need to be at least 18 years old and have certain breathing issues, specifically high levels of carbon dioxide and low blood pH, indicating respiratory failure. They also need to provide written consent to join the study. Throughout the trial, participants will undergo tests to check their breathing and vital signs, and the researchers hope to find the best way to support patients’ breathing during FOB. This study is important because it could lead to improved care for patients facing serious breathing challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients ≥ 18 years of age with indications for bronchoscopy:
  • Therapeutic examination: pneumonia in people with impaired cough reflex, culture and toilet of the bronchial tree, respiratory tract hemorrhages treated with a bronchofiberoscope and aspiration of a foreign body, bronchial unblocking in advanced neoplastic disease.
  • 2. Patient who signed a written informed consent to participate in the study,
  • 3. pCO2 \> 45 mmHg and pH \< 7.35 in a blood gas analysis performed directly during qualification for FOB.
  • Exclusion Criteria:
  • 1. Lack of written, informed consent of the subject to participate in the research project,
  • 2. Unstable coronary artery disease chronic coronary syndrome (CCS) III/IV, circulatory failure New York Heart Association (NYHA) III/IV (does not apply to tests for vital indications, e.g. aspiration of a foreign body),
  • 3. Hemodynamic insufficiency, constant use of pressor amines, myocardial infarction in the last 2 weeks without percutaneous coronary intervention (PCI) treatment, unstable angina pectoris, severe arrhythmias- especially ventricular,
  • 4. Chronic primary pulmonary hypertension, assessed during right heart catheterization WHO III/IV,
  • 5. Pneumothorax not secured with drainage,
  • 6. Platelet count \<20,000/µl, if platelets are not transfused immediately before or during the procedure,
  • 7. International normalized ratio (INR)\> 2 or activated partial thromboplastin time (APTT) \> 36 s, in the case of therapeutic FOB \[16\],
  • d. Anemia: hemoglobin (Hb) level \<6 g/dl or 6-10 g/dl if the physician prescribes a blood transfusion, h. 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.

Locations

Patients applied

0 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