Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on Continuous Positive Airway Pressure: the DREAM Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
研究概览
简要总结
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.
The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants.
The study's secondary objectives are:
- To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants.
- To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
详细描述
Cardiorespiratory events, defined by the occurrence of apneas, bradycardias, and desaturations, are almost ubiquitous in very preterm infants and are associated with numerous complications. Unfortunately, the current standard for monitoring cardiorespiratory events in the NICU, transthoracic impedance (TTI), does not permit for accurate differentiation of the different types of cardiorespiratory events; TTI cannot detect airflow and has low accuracy for detecting respiratory efforts. As a result, TTI does not detect obstructive apneas and may not reliably capture all central apneas.
Respiratory sounds are an attractive surrogate measure of airflow, and can be captured using respiratory acoustic technology (akin to a miniaturized electronic stethoscope). We hypothesize that respiratory acoustic monitoring can provide a continuous, non-invasive, and accurate representation of airflow and breathing sounds in preterm infants.
Altogether, we conjecture that the combination of respiratory acoustic monitoring with measurements of respiratory effort will improve the ability to differentiate and describe the nature of cardiorespiratory events in preterm infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 72 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for all infants:
- •Gestational age < 32+0 weeks
- •Postmenstrual age between 28+0 and 36+6 weeks.
- •Additional inclusion criteria for Groups 1 and 2:
- •Off any respiratory support and breathing in-room air
- •Less than 3 clinically significant cardiorespiratory events per calendar day
- •Additional inclusion criteria for Group 3:
- •On the bubble CPAP device with the binasal prongs interface
- •Receiving CPAP levels of 5 to 7 cm H2O with gas flows not exceeding 10L/min
- •At least 3 clinically significant cardiorespiratory events per calendar day
排除标准
- •Major known congenital abnormalities
- •Known congenital heart disorders
- •Known neuromuscular disease
- •Known diaphragmatic paralysis or a diagnosed phrenic nerve injury
- •History of esophageal perforation in the 7 days preceding the study
- •History of pneumothorax requiring chest tube insertion in the 7 days preceding the study
- •Receiving inotropes, narcotics, or sedative agents at the time of study recording
- •Additional exclusions at the time of the study recording:
- •Infants receiving ventilator-derived CPAP
- •Infants receiving CPAP via a nasal mask interface.
- •Infants receiving inotropes, narcotics or sedative agents
- •Infants deemed clinically unstable for the study by the attending neonatologist.
结局指标
主要结局
Reliability of respiratory acoustics at detecting airflow compared to airflow measurements obtained from a pneumotachometer.
时间窗: 10 minutes (group 1) or 3 hours (groups 2 and 3)
The airflow signal derived from the respiratory acoustic sensor will be compared with the airflow signal derived from the pneumotachometer.
次要结局
- Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Respiratory Inductance Plethysmography (RIP).(3 hours (groups 2 and 3 only))
- Reliability of the inertial measurement unit (IMU) at detecting respiratory efforts compared to Transthoracic Impedance (TTI).(3 hours (groups 2 and 3 only))
研究者
Wissam Shalish
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre