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临床试验/NCT06579157
NCT06579157招募中不适用

The Association Between Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
ballistocardiography waveform

研究概览

简要总结

This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

详细描述

Background: Traditional physiological measurement methods often require subjects to remain immobile or have various devices attached to their bodies, causing discomfort, especially unsuitable for neonatal care. However, with the development of electronic technologies, these methods have improved. ballistocardiography (BCG) presents a possible solution for monitoring neonates' physiological signals. BCG is a non-invasive and non-contact instrument that measures the body's reactive motion pressure changes caused by cardiac contraction. These sensors do not require direct attachment, allowing for long-term physiological signal measurement without disturbing the subject.

Methods: The study will be conducted in the neonatal intensive care unit on the seventh floor of Fu Jen Catholic University Hospital, with an expected enrollment of 60 participants. The subjects will be grouped and stratified based on weight and the use of invasive respiratory support. During the hospitalization, daily output of ventilator data and physiological monitor data will be collected and analyzed for correlation.

Effect: This trial is expected to confirm the application of BCG in the neonatal population, demonstrate its correlation with current conventional physiological monitors, and assess its applicability in low-weight preterm infants. Additionally, the study will investigate whether continuous BCG monitoring during hospitalization can predict the possibility of bronchopulmonary dysplasia.

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
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Using invasive ventilation support with flow sensors or non-invasive ventilation support
  • The legal representative signs the informed consent form

排除标准

  • Refusal to participate in the study

结局指标

主要结局

ballistocardiography waveform

时间窗: through study completion, an average of 2 weeks

the correlation between using Ballistocardiography (BCG) for monitoring respiration and heart rate

次要结局

  • tidal volume(through study completion, an average of 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (1)

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