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To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure).
Sponsor: Medical University of Silesia
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.
Official title: To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2025-10-01
Completion Date
2028-10-31
Last Updated
2025-05-14
Healthy Volunteers
No
Interventions
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.
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.