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.
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.
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,
Parallel
Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure
DeviceThe 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
DeviceThe 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.
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Treatment groupsSee each treatment group below.
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,
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,
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.
HFNC device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures
For therapeutic FOB the HFNC setting will be set to: HFNC, flow 60L/min, temperature 34oC and FiO2 under saturation control to achieve SpO2≥92% Baseline FiO2 - equivalent to FiO2 during oxygen therapy before FOB (during hospitalization), During FOB all needed changes in settings for a safe procedures will be marked, by measurment of parameters for the optimal setting choice: 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.
NIV device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures
For therapeutic FOB the NIV setting will be set to: NIV will be conducted in ST mode (spontaneous to forced), number of breaths 16-18/minute, EPAP (positive expiratory pressure) 6-14 cmH2O, Tins (duration) 0.8-1s, PS (pressure support ventilation) 8-25 cm H2O and oxygen flow under saturation control to achieve SpO2≥92% (baseline oxygen with FiO2 - at the level of previously administered FiO2, trigger and low cycle During FOB all needed changes in settings for a safe procedures will be marked, by measurment of parameters for the optimal setting choice: 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.
MV device setting for patients with type 2 respiratory failure undergoing bronchoscopic procedures
For therapeutic FOB the MV setting will be set to: MV: device parameters will correspond to previous settings to achieve SpO2≥92%, based on minute ventilation and tidal volume. The initial mode used should be recorded, including PS, EPAP, and FiO2. For intubated patients, the endotracheal tube size should be recorded. During FOB all needed changes in settings for a safe procedures will be marked, by measurment of parameters for the optimal setting choice: 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.
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