Status:

NOT_YET_RECRUITING

Respiratory Stabilization in Chronic Acidosis Before Bronchofiberoscopy & Non-Invasive Ventilation Effectivenes

Lead Sponsor:

Medical University of Silesia

Conditions:

Chronic Respiratory Acidosis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Bronchofiberoscopy (FOB) is a minimally invasive and safe procedure performed for diagnostic and therapeutic purposes. FOB frequently impairs respiratory function, which may lead to possible exacerbat...

Detailed Description

Project description Assessment of the importance of respiratory stabilization in patients with chronic respiratory acidosis before undergoing bronchofiberoscopy for diagnostic purposes, as well as the...

Eligibility Criteria

Inclusion

  • Patient ≥ 18 years of age with indications for diagnostic bronchoscopy:
  • ◦ Diagnostic test: suspected lung cancer, suspected sarcoidosis, mediastinal lymphadenopathy,
  • Patient who signed a written informed consent to participate in the study,
  • 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

  • Lack of written informed consent of the subject to participate in the research project,
  • Coronary artery disease CCS III/IV,
  • Hemodynamic failure, use of pressor amines, myocardial infarction in the last 2 weeks without PCI treatment, unstable angina pectoris, severe arrhythmias - especially ventricular,
  • Pneumothorax not secured with drainage,
  • Platelet count \<20,000/µl, if platelets are not transfused immediately before/during the procedure,
  • INR \> 1.5xULN or APTT \>36 s.1.5xULN, in the case of diagnostic FOB \[16\],
  • Anemia: hemoglobin (Hb) level \<6 g/dl or 6-10 g/dl if the physician prescribes a blood transfu-sion,
  • Patients who were intubated before randomization.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2028

Estimated Enrollment :

210 Patients enrolled

Trial Details

Trial ID

NCT06970002

Start Date

October 1 2025

End Date

October 31 2028

Last Update

May 14 2025

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