NCT01565226已完成不适用
Capnography in Neonates Ventilated With High Frequency Ventilation: Prospective, Observational Multi-Center Study
Oridion3 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.
研究概览
简要总结
- This will be an observational study. Respiratory data will be recorded using Capnostream20p. There will be no use in the recorded data for the medical care of the patients. Other clinical data will be captured in the CRF. Similar study is currently conducted in Bnai Zion MC since 2008. Thirty four (34) patients have been recruited without any adverse events.
- During the study the medical team will capture in the CRF the following: Blood gas and distal capnography values at time of sampling, ventilator settings at time of sampling.
- Changes made in the ventilation parameters, blood gas time and results, concomitant treatment (e.g. suction) and concomitant medication (respiratory related e.g. surfactant), vital signs all these will be retrieved from the patient's medical charts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico)
- •Neonates that their respiratory condition requires HFV
- •Neonates expected to have at least 3 pairs of distal capnography measurements and blood gas samplings.
排除标准
- •Intubated neonates with single-lumen ETTs
- •Neonates who are ventilated with conventional ventilation
- •Any significant medical condition which, at the investigator's discretion, may interfere with the study.
结局指标
主要结局
Evaluate the feasibility of measuring distal capnography on HFV and to assess its correlation and agreement with PaCO2 in infants ventilated with HFV in a prospective study.
时间窗: August 2012 - February 2015
次要结局
未报告次要终点
研究者
研究点 (3)
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