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临床试验/NCT07542301
NCT07542301招募中不适用

Breathing Patterns in Infants Before and After Extubation

Christiana Care Health Services1 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14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
Work of breathing before and after extubation

研究概览

简要总结

The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU.

详细描述

For clinicians, the ability to accurately predict which infants will successfully extubate is essential. Doctors and nurses routinely use a combination of vital signs (heart rate, respiratory rate, oxygen saturations), physical examination and spontaneous breathing trials to determine a baby's readiness to have their breathing tube removed. A spontaneous breathing trial is routinely done in our NICU and involves reducing the support that the baby receives from the breathing machine while leaving the breathing tube in place. These methods do not always accurately predict which babies are ready to be extubated.

This prospective observational pilot study will measure work of breathing (how hard or how easy a baby breathes) before, during and after the routine spontaneous breathing test is done. The study will also measure work of breathing before and after removal of the breathing tube, if a baby's medical team decides the baby is ready to have their tube removed.

Work of breathing indices will be measured through respiratory inductive plethysmography (RIP). Soft elastic cloth bands will be placed around the baby's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes. We hypothesize that PneuRIP can predict extubation failure.

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
0 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • premature infants (born at ≤32 weeks gestation) who are intubated.
  • medical team is evaluating the baby for extubation readiness

排除标准

  • Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of RIP measurements will be excluded.

研究组 & 干预措施

Preterm infants who are intubated

There is only one cohort for this study and it includes preterm infants who are intubated.

干预措施: Observation (Other)

结局指标

主要结局

Work of breathing before and after extubation

时间窗: 25 minutes

The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. We will observe work of breathing for 5-10 minutes before the infant is extubated and 5-10 minutes after the infant is extubated.

次要结局

  • Ability of work of breathing indices to predict extubation failure.(25 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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