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

NCT06970041 | Not Yet Recruiting

• 1 other identifier: BNW/NWN/0052/KB1/96/I/24/25
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

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 possible exacerbation of respiratory failure. Currently, the most frequent respiratory support is passive oxygen therapy, but non-invasive ventilation (NIV) and high flow nasal cannula (HFNC) are increasingly attempted, however the optimal setting and indications for NIV and HFNC in patients undergoing FOB with respiratory acidosis, haven't been determined yet. Methods: The study protocol describes a prospective, multicenter, three-armed randomized controlled trial (RCT). The investigators aim to study patients undergoing a therapeutic bronchofiberoscopy with decompensated type 2 respiratory failure: (pH \<7.35 and pCO2 \>45 mmHg);

1. 1.randomized to: passive oxygen, NIV, HFNC, invasive mechanical ventilation (IMV);
2. 2.total number of participants: 315. Before FOB, the patient group will undergo arterial blood gas analysis (ABG). During FOB there will be a continuous monitoring of vital signs as in: SpO2, FiO2, TcCO2, ECG, and Heart Rate. After FOB, the investigators are going to perform another ABG, mark endpoints, and complications, if any arise.

Conditions

Respiratory Failure With Hypercapnia; Therapeutic Bronchofiberoscopy

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)

Outcome Measures

Primary Outcomes (3)

• NIV allows for a safe therapeutic bronchoscopy in patients with type 2 respiratory failure.

  The investiagators are going to asses the performance of NIV in patients with type 2 respiratory failure undergoing a therapeutic FOB marking endpoints such as: * Hypoxemia, decrease in saturation \>5% for more than 30 seconds, * PO2 before and after FOB from blood gas analysis, * PO2/FiO2 before and after FOB from blood gas analysis, * Hypercapnia measured transcutaneous TcCO2, increase in PCO2 \>10 mm Hg for more than 30 seconds during the study, * PCO2 before and after FOB from blood gas analysis, * pH before and after FOB from blood gas analysis, * Need to extend NIV therapy after FOB - \[time in minutes\], * Need to escalate NIV therapy, NIV -\> intubation,

  During the procedure, and after up to the arterial blood gas analysis (1day)

• HFNC allows for a safe therapeutic bronchoscopy in patients with type 2 respiratory failure.

  The investiagators are going to asses the performance of HFNC in patients with type 2 respiratory failure undergoing a therapeutic FOB marking endpoints such as: * Hypoxemia, decrease in saturation \>5% for more than 30 seconds, * PO2 before and after FOB from blood gas analysis, * PO2/FiO2 before and after FOB from blood gas analysis, * Hypercapnia measured transcutaneous TcCO2, increase in PCO2 \>10 mm Hg for more than 30 seconds during the study, * PCO2 before and after FOB from blood gas analysis, * pH before and after FOB from blood gas analysis, * Need to extend HFNC therapy after FOB - \[time in minutes\], * Need to escalate HFNC therapy, HFNC-\> NIV; NIV -\> intubation,

  During the procedure, and after up to the arterial blood gas analysis (1day)

• The number of complications after a therapeutic FOB in patients with type 2 respiratory failure

  Endpoints and complications such as prolonged hospitalization, bronchospasm, hypoxemia episode, decompensated respiratory acidosis, local bleeding, fever, need to interrupt the procedure, transfer to the ICU, pneumothorax, death will be marked.

  Through study completion, an average of 1 years

Secondary Outcomes (3)

• HFNC device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures

  During the procedure, and after up to the arterial blood gas analysis (1day)

• NIV device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures

  During the procedure, and after up to the arterial blood gas analysis (1day)

• MV device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures

  During the procedure, and after up to the arterial blood gas analysis (1day)

Study Arms (7)

pH < 7,2, NIV

ACTIVE COMPARATOR

The use of NIV in patients undergoing therapeutic FOB with the most severe type 2 respiratory failure

Device: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure

pH < 7,2, IMV (Intubation)

NO INTERVENTION

The use of IMV in patients undergoing therapeutic FOB with the most severe type 2 respiratory failure (current gold standard at ICU fascilities)

7,3> pH ≥ 7,2, NIV

ACTIVE COMPARATOR

The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3\> pH ≥ 7,2.

Device: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure

7,3> pH ≥ 7,2, HFNC

ACTIVE COMPARATOR

The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3\> pH ≥ 7,2.

Device: Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure

7,35> pH ≥ 7,3, NIV

ACTIVE COMPARATOR

The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\> pH ≥ 7,3

Device: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure

7,35> pH ≥ 7,3, HFNC

ACTIVE COMPARATOR

The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\> pH ≥ 7,3

Device: Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure

7,35> pH ≥ 7,3, Passive Oxygen Therapy (control group)

NO INTERVENTION

The use of passive oxygen therapy (current gold standard) in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\> pH ≥ 7,3

Interventions

Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure DEVICE

The aim of the project is to assess the safety, indications and contraindications for therapeutic bronchofiberoscopy in patients with decompensated respiratory acidosis using: invasive mechanical ventilation (IMV), non-invasive mechanical ventilation (NIV) and high-flow nasal canulla (HFNC). Additionally, we want to determine to what extent the use of respiratory support during bronchofiberoscopy (BF) will avoid complications such as exacerbation of hypoxemia and/or acidosis and the occurrence of hemodynamic instability.

7,35> pH ≥ 7,3, NIV; 7,3> pH ≥ 7,2, NIV; pH < 7,2, NIV

Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure DEVICE

The aim of the project is to assess the safety, indications and contraindications for therapeutic bronchofiberoscopy in patients with decompensated respiratory acidosis using: invasive mechanical ventilation (IMV), non-invasive mechanical ventilation (NIV) and high-flow nasal canulla (HFNC). Additionally, we want to determine to what extent the use of respiratory support during bronchofiberoscopy (BF) will avoid complications such as exacerbation of hypoxemia and/or acidosis and the occurrence of hemodynamic instability.

7,35> pH ≥ 7,3, HFNC; 7,3> pH ≥ 7,2, HFNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Szymon Skoczyński, PhD, professor of university

  Department of Lung Diseases and Tuberculosis, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikołaj Rycerski, Student

CONTACT

+48530379348; miko.ryc99@gmail.com

Szymon Skoczyński, PhD, professor of university

CONTACT

simon.mds@poczta.fm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 14, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-04