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

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. randomized to: passive oxygen, NIV, HFNC, invasive mechanical ventilation (IMV);
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.

Results:

Based on the selected endpoints, or any complication related to FOB the investigators hope to determine which of the respiratory methods: passive oxygen, NIV, HFNC or IMV provides the best support, leading to a lower number of complications and overall a better tolerance of FOB by the patient. Additionally, our aim is to find the optimal settings for NIV and HFNC in the studied group.

Conclusions:

The results of this study are going to assess the need and the role of the optimal respiratory support method among patients with exacerbation of respiratory acidosis, leading to a shorter time from admission to full recovery, better tolerance during the procedure, quicker recovery after procedure.

Conditions

• Respiratory Failure With Hypercapnia
• Therapeutic Bronchofiberoscopy

Interventions

DEVICE

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

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.

DEVICE

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

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.

Sponsors & Collaborators

• Medical University of Silesia

  lead OTHER

Principal Investigators

• Szymon Skoczyński, PhD, professor of university · Department of Lung Diseases and Tuberculosis, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2028-10-31

Completion

2028-10-31