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Enrolling By Invitation
NCT05655026
NIV-FOB, HFNC-FOB- Comparison of Methods
Conditions: Respiratory Failure, Hypoxemia, Hypoxemic Respiratory Failure
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 300
Sponsor: Medical University of Silesia
Location: Poland
Summary
The aim of the study is to asses safety and indications and contraindications for performing bronchofiberocopy (FB) with respiratory support methods, i.e. non-invasive ventilation (NIV) and high flow nasal oxygen therapy (HFNO).
Additionally, researchers want to determine how using these methods could avoid the risk of most common complications such as: hypoxemia-related events, decompensation of chronic respiratory failure, worsening of gas exchange, hemodynamic instability.
Eligibility Criteria
Inclusion Criteria:Patient ≥ 18 years, with indications for bronchoscopy,Diagnostic procedure: lung cancer, hemoptysis, BAL in interstitial lung diseases.Therapeutic procedure: pneumonia in patients with impaired cough reflex, performed to obtain sputum cultures and bronchial tree toilet, hemoptysis or foreign body aspiration in patients not requiring rigid bronchoscopic management.Written informed consent to participate in the study,PO2/fiO2≤300 in blood gas test performed directly (within 24 h) during the qualification for FBExclusion Criteria:No willingness to participate,PO2/fiO2>300 in arterial blood gases, severe unstable coronary artery disease (CCS III/IV), NYHA III/IV,Hemodynamic instability defined as continuous amine influx.
Myocardial infarction during the last 2 weeks, without PCI treatment.
Unstable angina, severe arrhythmias - especially ventricular,Chronic primary pulmonary hypertension confirmed by right heart catherisation in WHO III/IV,Unsecured by chest tube pneumothorax,Platelet count <20,000 /µl (without platelet transfusion),INR >2 or APTT >36 s., in case of diagnostic FB [18]The study will also not include patients who were intubated before randomization.
Source: ClinicalTrials.gov (NCT05655026). StuddyBuddy aggregates publicly available trial information.
