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临床试验/NCT07060833
NCT07060833招募中不适用

The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Pressure

研究概览

简要总结

This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP 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 main goals are:

  1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.
  2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.
  3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.

详细描述

Continuous positive airway pressure (CPAP) is an essential, non-invasive therapy for treating various respiratory conditions in the Neonatal Intensive Care Units (NICU). CPAP is an effective treatment for respiratory distress syndrome, apneas, or after extubation, exerting its physiological benefits by maintaining upper airway patency and functional residual capacity. Bubble CPAP (bCPAP) is the most widely used CPAP due to its low cost and ease of use. It consists of an inspiratory tube carrying heated and humidified air, a nasal interface, and an expiratory tube immersed in a water chamber. The generation of bubbles in the water chamber by exhaled gas creates low amplitude and high-frequency pressure oscillations that are transmitted back to the chest. Successful CPAP requires constant transmission of the pressure via an unobstructed circuit. However, this is difficult to achieve in practice due to inadequate interface, leaks from an open mouth, and obstructed airway. As a result, bCPAP requires frequent manual checks by nurses and respiratory therapists to ensure that the circuit is secure and unobstructed.

As a proposed solution, bCPAP sounds heard in the patient room or upon auscultation are routinely used to assess the effectiveness of CPAP therapy. This sound can be heard both from the water tank creating the vibrations and during auscultation with a stethoscope, as the sound vibration is transmitted to the neonatal lungs. In the current era of digital technology, acoustic sounds can be converted to electronic signals for further processing and analysis.

We hypothesize that continuous recording and analysis of bCPAP sounds could be used as a proxy for real-time objective monitoring of the pressure transmitted to infants' lungs.

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
28 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants on bCPAP with gestational age < 32+0 weeks
  • Postmenstrual age between 28+0 and 36+6 weeks at the time of the study
  • Postnatal age greater than 168 hours (7 days) at the time of the study
  • On the bubble CPAP device with binasal prongs at the time of the study
  • Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study

排除标准

  • Infants with known major congenital anomalies
  • Infants with known congenital heart disorders
  • Infants with known neuromuscular disease
  • Infants receiving ventilator-derived CPAP at the time of the study
  • Infants receiving CPAP via a nasal mask interface at the time of the study
  • Infants receiving inotropes, narcotics or sedative agents at the time of the study
  • Infants deemed clinically unstable for the study by the attending neonatologist

结局指标

主要结局

Pressure

时间窗: 3 hours

The mean pressure and the standard deviation of the pressure will be computed for each segment.

External bubble CPAP sounds

时间窗: 3 hours

Two metrics will be computed: 1. The root mean square (RMS) 2. The power contained between a pre-determined range within each segment; We will determine the range that contains 80% of the signal power, in order to minimize other noises from bubble CPAP signal.

Internal bubble CPAP sounds

时间窗: 3 hours

1. We will apply biomedical signal processing methods to separate the bubbling sounds from breathing sounds. Then, RMS and power will be computed. 2. We will use the Pearson correlation coefficient to compute the relationship between bubbling sound and pressure metrics. We will evaluate the linear regression models to identify the combination of sound metrics and covariates with the highest predictive accuracy.

次要结局

未报告次要终点

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wissam Shalish

Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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