Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Medical University of Silesia

Conditions:

Respiratory Failure With Hypercapnia

Therapeutic Bronchofiberoscopy

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

Detailed Description

To assess the types of mechanical ventilation in enabling therapeutic bronchofiberoscopy in patients with decompensated respiratory acidosis (complete respiratory failure). The aim of the project The...

Eligibility Criteria

Inclusion

  • 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.
  • Patient who signed a written informed consent to participate in the study,
  • pCO2 \> 45 mmHg and pH \< 7.35 in a blood gas analysis performed directly during qualification for FOB.

Exclusion

  • Lack of written, informed consent of the subject to participate in the research project,
  • 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),
  • 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,
  • Chronic primary pulmonary hypertension, assessed during right heart catheterization WHO III/IV,
  • Pneumothorax not secured with drainage,
  • Platelet count \<20,000/µl, if platelets are not transfused immediately before or during the procedure,
  • 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.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2028

Estimated Enrollment :

315 Patients enrolled

Trial Details

Trial ID

NCT06970041

Start Date

October 1 2025

End Date

October 31 2028

Last Update

May 14 2025

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