跳至主要内容
临床试验/NCT06535074
NCT06535074招募中不适用

Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年4月4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
35
试验地点
2
主要终点
Frequency of hypoxemia episodes of each subtype

研究概览

简要总结

Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.

详细描述

This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Born at ≤32w GA
  • Post menstrual age between 30w to 36w
  • 4 or more episodes of HEs in the previous 24h (Defined as SpO2<90≥5s)

排除标准

  • Major congenital malformation
  • Receiving invasive mechanical ventilation
  • Severe neurological injury
  • Hemodynamic instability requiring inotropes in last 72h

结局指标

主要结局

Frequency of hypoxemia episodes of each subtype

时间窗: 6 hour

Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters.

次要结局

  • Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia(6hr)
  • Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes(6hr)
  • Mean highest change in CrSO2 and cFToE during HEs and each subtype(6hr)

研究者

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

Deepak Jain. MD

Professor of Pediatrics

Rutgers, The State University of New Jersey

研究点 (2)

Loading locations...

相似试验