Sonographic Evaluation of Diaphragmatic Function Under Nasal High-flow (NHF) and Non-invasive Ventilation (NIV) in Respiratory Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Sonographic measurements of diaphragm thickness
研究概览
简要总结
The aim of the study is to investigate the influence of respiratory support on diaphragmatic function (O2, NHF, NIV). The effects on the diaphragm, the respiratory values (FEV1, respiratory rate) and the subjective well-being of the patients during the therapy phases will be measured.
The primary objective of the clinical study is to investigate the differences in respiratory support with regard to the change in diaphragmatic kinetics and morphology (Tdi; TEx; Tdi, ee, Tdi, pi, ΔTdi, TFdi) as a function of respiratory rate.
For both ventilation modes, the influence on the respiratory situation, the respiratory muscle pump and adverse events will also be analysed. This is done using defined variables (FEV1, FEV1%VC, respiratory rate, frequency and type of adverse events (AEs), subjective satisfaction with the test product (Borg scale)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute or chronic respiratory insufficiency with and/or hypercapnia,
- •age > 18 years.
- •tolerate respiratory support devices
- •to sign a written declaration of consent
排除标准
- •Presence of respiratory insufficiency requiring intubation,
- •clinical instability,
- •metabolic acidosis or alkalosis,
- •Contraindication for NIV according to the S3 guideline,
- •serious concomitant illnesses,
- •unwillingness to co-operate
研究组 & 干预措施
Nasal high flow
干预措施: Nasal high flow (Device)
NIV
干预措施: NIV (Device)
结局指标
主要结局
Sonographic measurements of diaphragm thickness
时间窗: after 30 minutes use
Tdi ee in mm = Diaphragm thickness is determined by measuring the distance between the diaphragmatic pleura and the diaphragm/peritoneum border at maximum expiration
次要结局
- Tdi pi(30 minutes)
- TF di(30 min)
- DEx(30 minutes)
- FEV1(30 min)
- Respiratory rate(30 min)
- Tiffeneau - index(30 min)
研究者
Jens Bräunlich
Clinical director, Head of department
Klinikum Emden