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临床试验/NCT04089956
NCT04089956已完成不适用

Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury

Southeast University, China1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
extubation Success

研究概览

简要总结

Esophageal recordings of diaphragm electrical activity (EAdi) made it possible to monitor respiratory drive and the subsequent phrenic nerve conduction and respiratory neuromuscular function continuously. Thus, we designed a "spontaneous breathing challenge" test to monitor the change in EAdi after a maximal inspiration. We hypothesized that the absolute change (ΔEAdi) and the percentage changes change (ΔEAdi%) in EAdi after a "spontaneous breathing challenge" predict successful extubation in traumatic CSCI patients during acute hospitalization.

详细描述

A retrospective cohort study enrolled adult traumatic CSCI patients who underwent mechanical ventilation and admitted to the intensive care unit (ICU) of Zhongda hospital form June 2014 to July 2018. The following inclusion criteria were used: age 18 years or older, traumatic CSCI patients with a neurologic level of injury of C1 to C8 by the American Spinal Injury Association (ASIA) standard impairment scale grade A-D patients with mechanical ventilation due to acute respiratory failure and admite to ICU, dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in postion. CSCI was defined as radiologically-confirmed injury to the cervical spinal column, combined with clinical signs and symptoms consistent with CSCI at that level. The exclusion criteria were: tracheostomy at time of addmition to ICU, withhold or withdraw life sustaining treatment due to other serious organ injury, can't complete instructional actions, death occurred within 7 days after injury, or postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively. Extubation or tracheostomy was decided by the physician in charge according to the local protocol of weaning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • age 18 years or older
  • Traumatic CSCI patients with a neurologic level of injury of C1 to C8 by the American Spinal Injury Association (ASIA) standard impairment scale grade A to D
  • patients with mechanical ventilation due to acute respiratory failure and admit to ICU
  • with dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in position.

排除标准

  • tracheostomy before ICU admission
  • withhold or withdraw life sustaining treatment due to other serious organ injury
  • can't complete instructional actions,
  • death occurred within 7 days after injury
  • postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively.
  • EAdi data not available

结局指标

主要结局

extubation Success

时间窗: up to 90 days

defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay

次要结局

  • ventilator free days(up to 28 days)
  • complications(up to 90 days)
  • mortality(up to 90 days)
  • length of stay(up to 90 days)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Principal Investigator

Southeast University, China

研究点 (1)

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