High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Arterial blood gases at end of the procedure
研究概览
简要总结
The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia.
Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography).
Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.
详细描述
Patients with Acute Respiratory Failure may sometimes require a bronchial endoscopy for broncho-alveolar lavage (BAL).
During the procedure, hypoxemia may worsen and oxygen may be require to avoid desaturation.
In the recent years, High-Flow through Nasal Cannula (HFNC) has been introduced in the clinical practice. HFNC delivers to the patient heated humidified air-oxygen mixture, with an inspiratory fraction of oxygen (FiO2) ranging from 21 to 100% and a flow up to 60 L/min through a large bore nasal cannula.
HFNC has some potential advantages. First of all, HFNC provides heated (37°C) and humidified (44 mg/L) air-oxygen admixture to the patient, which avoids injuries to ciliary motion, reduces the inflammatory responses associated to dry and cold gases, epithelial cell cilia damage, and airway water loss, and keeps unmodified the water content of the bronchial secretions. Second, HFNC determines a wash out from carbon dioxide of the pharyngeal dead space. Third, HFNC generates small amount (up to 8 cmH2O) of pharyngeal pressure during expiration, which drops to zero during inspiration. Fourth, HFNC guarantees a more stable FiO2, as compared to conventional oxygen therapy. Whenever the inspiratory peak flow of a patient exceeds the flow provided by a Venturi mask, the patient inhaled also part of atmospheric air.
Electrical impedance tomography (EIT) is a noninvasive imaging technique providing instantaneous monitoring of variations in overall lung volume and regional distribution of ventilation, as determined by variations over time in intrathoracic impedance, which is increased by air and reduced by fluids and cells. EIT allows determining changes in end-expiratory lung impedance (EELI), a surrogate estimate of end-expiratory lung volume, assessing global and regional distribution of Vt, and obtaining indexes of spatial distribution of ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •need for bronchial endoscopy for bronchoalveolar lavage
排除标准
- •life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
- •need for invasive or non invasive ventilation
- •presence of pneumothorax or pulmonary enphisema or bullae
- •recent (within 1 week) thoracic surgery
- •presence of chest burns
- •presence of tracheostomy
- •pregnancy
- •nasal or nasopharyngeal diseases
- •lack of consent or its withdrawal
结局指标
主要结局
Arterial blood gases at end of the procedure
时间窗: After 0 minute from the end of the bronchial endoscopy
Arterial blood will be sample for gas analysis
次要结局
- Respiratory effort at the beginning of the bronchoscopy(5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment)
- Change of tidal volume in percentage (dVt%) from baseline at end of the procedure(After 0 minute from the end of the bronchial endoscopy, compared to baseline)
- Respiratory effort at end of the procedure(After 0 minute from the end of the bronchial endoscopy)
- Respiratory effort at baseline(After 0 minute from enrollment)
- Respiratory effort after bronchoscopy(After 10 minute from the end of the bronchial endoscopy)
- Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure(After 0 minute from the end of the bronchial endoscopy, compared to baseline)
- Change of end-expiratory lung impedance (dEELI) from baseline after bronchoscopy(After 10 minute from the end of the bronchial endoscopy, compared to baseline)
- Change of tidal volume in percentage (dVt%) from baseline at the beginning of bronchoscopy(5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline)
- Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the bronchoscopy(5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment, compared to baseline)
- Arterial blood gases at baseline(After 0 minute from enrollment)
- Change of tidal volume in percentage (dVt%) from baseline after bronchoscopy(After 10 minute from the end of the bronchial endoscopy, compared to baseline)
研究者
Federico Longhini
Principal Investigator
University Magna Graecia