Evaluation of Pulmonary Aeration and Muscle Thickening Fraction in Infants With Bronchiolitis Using a High-flow Nasal Cannula: Association of Electrical Impedance Tomography and Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- abdominal muscle thickening fraction
研究概览
简要总结
The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question[s] it aims to answer are:
- If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated
- If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluated
The belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance.
Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.
The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages.
详细描述
OBJECTIVES Main Objective To evaluate, in infants with respiratory failure secondary to bronchiolitis, the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC).
Secondary Objectives
- To evaluate whether there is a correlation between thickening fraction and respiratory distress score.
- To find values from the EIT data and the thickening fraction that can correlate with possible failure criteria for HFNC therapy.
- METHODS 5.1 Study Type and Location A prospective clinical study will be conducted in the Pediatric ICU of Hospital Israelite Albert Einstein from January 2024 to December 2025 5.2 Ethical Aspects This study will be submitted to the Ethics and Research Committee of the Hospital Israelite Albert Einstein. The risk of participating in this research is considered minimal, limited to the accidental loss of confidentiality of the data collected or to skin erythema at the site of application of the belt. Only after signing the informed consent form will the patient be prepared for the beginning of monitoring (Appendix 1) Protocol The tape will be installed around the chest before the start of the change in flow rates and monitoring with EIT will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance.
Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Patient will not know the flow rate sequence used during the assessment
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bronchiolitis
- •Use of HFNC
排除标准
- •Patients diagnosed with chronic diseases
结局指标
主要结局
abdominal muscle thickening fraction
时间窗: during procedure
to evaluate the abdominal muscle thickening fraction through ultrasound in infants with bronchiolitis using HFNC at 4 different flow rates, whether the abdominal muscle thickening fraction changes when the flow rate is changed
EELZ (end-expiration lung impedance)
时间窗: during procedure
to evaluate the EELZ through electrical impedance tomography in infants with bronchiolitis using HFNC at 4 different flow rates, whether there is a change in the EELZ when the flow rate is changed
diaphragm thickening fraction
时间窗: during procedure
to evaluate the diaphragm thickening fraction through ultrasound in infants with bronchiolitis using HFNC at 4 different flow rates, whether the diaphragm thickening fraction changes when the flow rate is changed
次要结局
未报告次要终点