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

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 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, two- armed randomized controlled trial (RCT).

The investigators aim to study two patients groups, based on FOB indications and the type of respiratory acidosis:

1\) Diagnostic FOB; patients with chronic respiratory acidosis (pH ≥7.35; pCO2 \> 45mmHg and/or HCO3- \>27 mmol/l);

1. randomized to: passive oxygen, NIV, HFNC;
2. total number of participants: 210

Randomization:

two-step randomization (1st randomization :a or b; 2nd randomization: i- iii method of respiratory support):

a. Stabilization of respiratory parameters before FOB (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \>27 mmol/l) i. NIV ii. HFNC iii. Passive oxygen therapy b. FOB right away (pH 7.35-7.45; pCO2 \>45 mmHg; HCO3- \> 27 mmol/l) i. NIV ii. HFNC

Before FOB, both groups 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 both studied groups.

Conclusions:

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

Conditions

• Chronic Respiratory Acidosis

Interventions

DEVICE

Use of NIV during FOB as a respiratory support method

The aim of this project is to assess the safety, indications and contrindications to perform bronchofiberoscopy for diagnostic purposes in patient with chronic respiratory acidosis with the use of Non-invasive Ventilation (NIV) and High Flow Nasal Cannula (HNFC). In addition we want to determine the extent to which the usage of respiratory support during bronchofiberoscopy (BF) will help to avoid complications such as hypoxemia, decompensation of chronic respiratory failure, deterioration of gas exchange and hemodynamic instability, as well as intubation.

DEVICE

Use of HFNC during FOB as a respiratory support method

The aim of this project is to assess the safety, indications and contrindications to perform bronchofiberoscopy for diagnostic purposes in patient with chronic respiratory acidosis with the use of Non-invasive Ventilation (NIV) and High Flow Nasal Cannula (HNFC). In addition we want to determine the extent to which the usage of respiratory support during bronchofiberoscopy (BF) will help to avoid complications such as hypoxemia, decompensation of chronic respiratory failure, deterioration of gas exchange and hemodynamic instability, as well as intubation.

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