跳至主要内容
临床试验/NCT07559669
NCT07559669尚未招募不适用

To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients

Shanghai Zhongshan Hospital0 个研究点目标入组 35 人开始时间: 2026年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35
主要终点
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.

研究概览

简要总结

This study intends to use ultrasound to measure the bilateral diaphragmatic ultrasound indicators in critically ill patients, focusing on the left diaphragm, and to explore the consistency and reliability among various ultrasound indicators to evaluate the diaphragmatic mobility

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ①Adult patients (≥18 years old) of both sexes;
  • In invasive group, intubation or tracheotomy was changed to 5L/min T-tube or tracheotomy mask oxygen inhalation;
  • Patients in non-invasive group were treated with mask oxygen 5L/min;
  • agree to participate in the trial and sign the informed consent;

排除标准

  • ①The diaphragm ultrasound operation site was too large to obtain images.
  • Diaphragmatic ultrasound images could not be obtained in any section;
  • The ultrasound image quality of any section was poor;
  • the presence of phrenic nerve injury/paralysis ⑤ pregnant women; ⑥ Neuromuscular diseases such as ALS and myasthenia gravis affect the evaluation of spontaneous breathing ⑦ Patients deemed by the investigator to be ineligible.

研究组 & 干预措施

Invasive respiratory support group

The subjects of ultrasound measurement were patients with invasive mechanical ventilation

Noninvasive respiratory support group

The subjects of ultrasound measurement were patients with non-invasive respiratory support

结局指标

主要结局

Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.

时间窗: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.

The main purpose is to verify the consistency of the two methods, Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.

次要结局

  • Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.(Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.)
  • Consistency of diaphragmatic excursion measurements between the standard position and the other five positions on the right side.(Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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Study on the Measurement Method of the Left Diaphragm | 临床试验