跳至主要内容
临床试验/NCT05951114
NCT05951114招募中不适用

The Development of Post-operative Respiratory Muscle Dysfunction in Neurosurgical Patients

Beijing Sanbo Brain Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Incidence of diaphragm dysfunction after neurosurgery

研究概览

简要总结

Respiratory muscle dysfunction may contribute to the development of postoperative pulmonary complications. However, it prevalence in patients receiving neurosurgery is largely unknown. Therefore, in present study, respiratory muscle function (measured by the ultrasound) and their correlation with the post-operative pulmonary complications will be analyzed.

详细描述

Postoperative pulmonary complications is common in patients receiving neurosurgery, and is associated with hospitalization cost and mortality. Respiratory muscle dysfunction is an important cause postoperative pulmonary complications, however, it's prevalence in patients receiving neurosurgery is unclear.

The diaphragm and abdominal expiratory muscles are the main inspiratory and expiratory driving muscles. Ultrasound can assess the function and morphology of these muscles invasively and in realtime. Studies has demonstrated their feasibility and repeatability in realtime monitoring of respiratory muscles.

In this study, our primary aim is to assess the respiratory muscle function after neurosurgery, and the correlation between diaphragm and expiratory muscle function. Our secondary aims including the correlation between the brain injury and the respiratory muscle function, and the impact of post-operative respiratory muscle dysfunction on the pulmonary complications.

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

入选标准

  • Informed consent
  • First elective operation during hospitalization

排除标准

  • Brain stem and spinal spine lesions
  • Preoperative chest imaging findings were abnormal
  • Mechanical ventilation was required before surgery
  • Clinical or radiological evidence of preoperative misaspiration
  • History of neurosurgery in the last 6 months
  • A history of neuromuscular disease
  • BMI≥35kg/m2
  • Pregnant women
  • Skin lesions detected by ultrasound

结局指标

主要结局

Incidence of diaphragm dysfunction after neurosurgery

时间窗: Within 24 hours after the completion of surgery

The diaphragm dysfunction is defined as the thickening fraction \< 20% under the maximum inspiration

次要结局

  • The correlation between the level of inflammation maker ILs and the diaphragm function(Within 24 hours after the completion of surgery)
  • The thickening fraction of expiratory muscles after surgery(Within 24 hours after the completion of surgery)
  • The length of ICU stay(Through study completion, an average of 1 month)
  • The correlation between the level of NSE and the diaphragm function(Within 24 hours after the completion of surgery)
  • The incidence of postoperative pulmonary complication(Through study completion, an average of 1 month)
  • Hospital mortality(Through study completion, an average of 1 month)
  • The length of hospital stay(Through study completion, an average of 1 month)
  • Duration of mechanical ventilation(Through study completion, an average of 1 month)
  • The correlation between the level of inflammation maker TNF-alpha and the diaphragm function(Within 24 hours after the completion of surgery)

研究者

发起方
Beijing Sanbo Brain Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhonghua Shi, MD, PhD

Deputy president of the department ICU

Beijing Sanbo Brain Hospital

研究点 (1)

Loading locations...

相似试验

Post-neurosurgical Respiratory Muscle Dysfunction | 临床试验