To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 315
- Primary Endpoint
- NIV allows for a safe therapeutic bronchoscopy in patients with type 2 respiratory failure.
Study Overview
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);
- randomized to: passive oxygen, NIV, HFNC, invasive mechanical ventilation (IMV);
- 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.
Detailed Description
To assess the types of mechanical ventilation in enabling therapeutic bronchofiberoscopy in patients with decompensated respiratory acidosis (complete respiratory failure).
The aim of the project 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, non-invasive mechanical ventilation (NIV) and high-flow nasal canulla (HFNC). Additionally, the investigators 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.
Project justification
Bronchofiberoscopy is a safe procedure that has great therapeutic value for respiratory diseases. BF plays an important role in the diagnosis of hemoptysis, respiratory infections, interstitial lung diseases, lung tumors, mediastinal lymphadenopathy, and evaluation of transplanted lungs. bronchoscopy may have therapeutic applications in cases of foreign body aspiration and the need to perform bronchial toilet.
Regardless of the indications, airway narrowing occurs during BF, which may exacerbate respiratory failure and secondarily influence the occurrence of cardiac and pulmonary complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
pH < 7,2, NIV
The use of NIV in patients undergoing therapeutic FOB with the most severe type 2 respiratory failure
Intervention: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure (Device)
pH < 7,2, IMV (Intubation)
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
The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3> pH ≥ 7,2.
Intervention: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure (Device)
7,3> pH ≥ 7,2, HFNC
The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3> pH ≥ 7,2.
Intervention: Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure (Device)
7,35> pH ≥ 7,3, NIV
The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35> pH ≥ 7,3
Intervention: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure (Device)
7,35> pH ≥ 7,3, HFNC
The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35> pH ≥ 7,3
Intervention: Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure (Device)
7,35> pH ≥ 7,3, Passive Oxygen Therapy (control group)
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
Outcomes
Primary Outcomes
NIV allows for a safe therapeutic bronchoscopy in patients with type 2 respiratory failure.
Time Frame: During the procedure, and after up to the arterial blood gas analysis (1day)
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.
Time Frame: During the procedure, and after up to the arterial blood gas analysis (1day)
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
Time Frame: Through study completion, an average of 1 years
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.
Secondary Outcomes
- 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))
- 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))