跳至主要内容
临床试验/NCT06443970
NCT06443970招募中不适用

Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants

Columbia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Change in cerebral oxygenation (C-rSO2)

研究概览

简要总结

Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.

详细描述

Respiratory failure in neonates frequently requires mechanical ventilation through an endotracheal tube (ETT). The presence of an ETT inhibits the infant's intrinsic ability to clear endogenous lung secretions effectively with compromised glottic closure and impaired muccociliary function, and thus regular supportive suctioning of the ETT is essential. The benefits of patent airway are evident, but adverse effects may also result from suctioning which are especially deleterious in extremely preterm infants with immature pulmonary and systemic hemodynamic function. These adverse effects include transient hypoxemia and oxygen desaturation, vasovagal reactions, altered central and cerebral hemodynamics, atelectasis, pneumothorax, and mucosal damage. The cardiorespiratory instability during ETT suctioning is partially attributed to alveolar decruitment and loss of lung volume from disconnecting the ETT from the ventilator circuit and negative suction pressure. Maintenance of lung volume is essential to optimize gas exchange and prevent ventilator induced lung injury. The magnitude of lung volume loss is related to catheter size and applied suctioning pressure and flow, highlighting the complexity of interaction between suction technique, lung mechanics and disease state. In accordance with industry standard codes, a high flow rate is essential to ensure the rapid removal of fluid and secretions from the desired site and the standard conventional wall (SCW) suction outlets provide a minimum flow of approximately 85 liters per minute. Such high flows can lead to endotracheal suctioning-induced alveolar decruitment that may of significant clinical relevance. Recently, a low flow technology suction device EXSALTA (ED) for clearing ETT secretions in patients on ventilators has been approved by FDA. The device uses peristaltic action to move fluids from the patient to a collection canister at a fixed flow rate of 1.4 L/min and eliminates the uncontrolled flow of air from the patient's lungs. The user selects a desired pressure level that is independent of the flow rate, a feature unavailable with SCW wall suction equipment used at patient's bedside. This exceptional microprocessor-controlled tabletop suction device, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and hypoxia associated with standard suctioning techniques. This study will examine the hypothesis that there will be significantly lower variations in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (c-FOE) with ED compared to SCW suction system during open or closed ETT suctioning. To test this hypothesis, the physiological consequences of two ETT suctioning systems in preterm and term infants will be evaluated using the following aims:

AIM 1. To compare the variations in HR (bpm), SpO2 (%), C-rSO2 (%), C-FOE (%) between ED and SCW suctioning systems during routine standard care open and closed ETT suctioning.

AIM II. To compare the incidence (episodes) of cardiorespiratory disturbances, i.e. bradycardia (HR<80 bpm) and/or hemoglobin oxygen desaturation (SpO2) < 80% for more than 10s during suctioning with ED and SCW suctioning system during routine standard care open and closed ETT suctioning.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Preterm and term infants with birth weight more than 1000g receiving ETT suctioning

排除标准

  • •Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.

研究组 & 干预措施

Exsalta Device suctioning

Experimental

干预措施: Exsalta Suction Device (Device)

Coventional wall suctioning

Active Comparator

干预措施: Exsalta Suction Device (Device)

结局指标

主要结局

Change in cerebral oxygenation (C-rSO2)

时间窗: Before suctioning (baseline) and up to 1-hour after suctioning

Measured as percent (%) change

Change in heart rate (HR)

时间窗: Before suctioning (baseline) and up to 1-hour after suctioning

Measured as beats per minute

Change in cerebral fractional oxygen extraction (c-FOE)

时间窗: Before suctioning (baseline) and up to 1-hour after suctioning

Measured as difference in SpO2 and C-rSO2 (%)

Change in oxygen saturation (SpO2)

时间窗: Before suctioning (baseline) and up to 1-hour after suctioning

Measured as percent (%) change

次要结局

  • Incidence of bradycardia(Before suctioning (baseline) and up to 1-hour after suctioning)
  • Incidence of hemoglobin oxygen desaturation(Before suctioning (baseline) and up to 1-hour after suctioning)

研究者

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

Rakesh Sahni

Professor of Pediatrics

Columbia University

研究点 (1)

Loading locations...

相似试验