Assessment of the Importance of Respiratory Stabilization in Patients With Chronic Respiratory Acidosis Before a Diagnostic Bronchofiberoscopy, as Well as the Effectiveness of Different Types of Non-invasive Ventilation During the Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 主要终点
- HFNC allows to perform a safe diagnostic FOB in patients with chronic hypercapnia (pCO2>45mmHg; pH 7.35-7.45; HCO3- >27mmol/L)
研究概览
简要总结
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:
- Diagnostic FOB; patients with chronic respiratory acidosis (pH ≥7.35; pCO2 > 45mmHg and/or HCO3- >27 mmol/l);
- randomized to: passive oxygen, NIV, HFNC;
- 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.
详细描述
Project description Assessment of the importance of respiratory stabilization in patients with chronic respiratory acidosis before undergoing bronchofiberoscopy for diagnostic purposes, as well as the effectiveness of different types of non-invasive ventilation during the procedure.
The aim of the project 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 the investigators 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.
Project justification Bronchofiberoscopy is a minimally invasive procedure performed for diagnostic and therapeutic purposes.
BF is a safe method with high diagnostic value for respiratory diseases. It helps in the diagnosis of hemoptysis, interstitial lung diseases, respiratory system neoplasms and mediastinal lymphadenopathy. In addition, BF can be used therapeutically in cases of foreign body aspiration, airway patency, e.g. in patients with pneumonia or tumors.
BF carries a risk of complications, such as worsening hypoxia, which may contribute to the exacerbation of respiratory failure and secondarily influence the occurrence of cardiac and pulmonary complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years of age with indications for diagnostic bronchoscopy:
- •◦ Diagnostic test: suspected lung cancer, suspected sarcoidosis, mediastinal lymphadenopathy,
- •Patient who signed a written informed consent to participate in the study,
- •pCO2 > 45 mmHg and/or HCO3- > 27 mmol/l but pH ≥ 7.35 in a blood gas test performed immediately before qualification for bronchoscopy.
排除标准
- •Lack of written informed consent of the subject to participate in the research project,
- •Coronary artery disease CCS III/IV,
- •Hemodynamic failure, use of pressor amines, myocardial infarction in the last 2 weeks without PCI treatment, unstable angina pectoris, severe arrhythmias - especially ventricular,
- •Pneumothorax not secured with drainage,
- •Platelet count <20,000/µl, if platelets are not transfused immediately before/during the procedure,
- •INR > 1.5xULN or APTT >36 s.1.5xULN, in the case of diagnostic FOB [16],
- •Anemia: hemoglobin (Hb) level <6 g/dl or 6-10 g/dl if the physician prescribes a blood transfu-sion,
- •Patients who were intubated before randomization.
结局指标
主要结局
HFNC allows to perform a safe diagnostic FOB in patients with chronic hypercapnia (pCO2>45mmHg; pH 7.35-7.45; HCO3- >27mmol/L)
时间窗: During the procedure, and after up to the arterial blood gas analysis (1day)
The investiagors aim to determine if using NIV or HFNC instead of passive oxygen support during the procedure in patients with chronic hypercapnia (pCO2\>45mmHg, pH 7.35-7.45, HCO3- \>27 mmol/L) results in better respiratory stabiliziation during the procedure without the need to escalate respiratory support therapy during and after the procedure, 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 HNFC therapy after FOB - \[time in minutes\], * Need to escalate HFNC therapy -\> NIV, NIV -\> intubation,
NIV allows to perform a safe diagnostic FOB in patients with chronic hypercapnia (pCO2>45mmHg; pH 7.35-7.45; HCO3- >27mmol/L)
时间窗: During the procedure, and after up to the arterial blood gas analysis (1day)
The investiagors aim to determine if using NIV instead of passive oxygen support during the procedure in patients with chronic hypercapnia (pCO2\>45mmHg, pH 7.35-7.45, HCO3- \>27 mmol/L) results in better respiratory stabiliziation during the procedure without the need to escalate respiratory support therapy during and after the procedure, 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 -\> intubation,
Optimal settings for HFNC in patients with chronic hypercapnia undergoing a diagnostic FOB
时间窗: During the procedure, and after up to the arterial blood gas analysis (1day)
Primarily the devices will be set to: - HFNC: flow 60L/min, temperature 34 ºC and FiO2 under saturation control to achieve SpO2≥ 92%, During FOB all needed changes in settings for a safe procedures will be marked, if the need for that arises. 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, A comaparison of BGA before and after the procedure will allow to determine if those settings and the method itself performs well.
Optimal settings for NIV in patients with chronic hypercapnia undergoing a diagnostic FOB
时间窗: During the procedure, and after up to the arterial blood gas analysis (1day)
Primarily the device will be set to: NIV will be conducted in ST mode (spontaneous to forced), number of breaths 16-18/minute, EPAP (expiratory positive pressure) 6-12 cmH2O, Tins (duration) 0.8-1.1s, PS 12-23 cm H2O and oxygen flow under saturation control to achieve SpO2≥ 92%, During FOB all needed changes in settings for a safe procedures will be marked, if the need for that arises. 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, A comaparison of BGA before and after the procedure will allow to determine if those settings and the method itself performs well.
The number of complications after a diagnostic FOB in patients with chronic hypercapnia
时间窗: 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.
次要结局
- NIV vs HFNC, is one better then the other to support a diagnostic BF in patients with chronic hypercapnia(Through study completion, an average of 1 year)