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临床试验/NCT02817035
NCT02817035已完成不适用

Study of Neural Inspiratory Time and Expiratory Delay in Patients and Healthy Subjects During Unassisted Spontaneous Breathing and Mechanical Ventilation.

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
neural inspiratory time

研究概览

简要总结

To make these definitions of neural inspiratory time (Ti) and expiratory delay clearly.The present study was undertaken to examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.

详细描述

In total, 8 chronic obstructive pulmonary disease (COPD) patients, 8 patients with interstitial lung disease (ILD) and 8 healthy subjects were recruited.

The patient was studied at the afternoon in a semirecumbent position. After the application of topical anaesthesia (2% xylocaine), the patient was asked to swallow two balloon-tipped catheters and the multi-pair esophageal electrode catheter through the nose into the their right position.

At the first period, the stable signals of unassisted spontaneous breathing (about 5min) were chosen to be recorded. After this period, the patient was placed on noninvasive pressure support ventilation(PSV). The inspiratory positive airway pressure (IPAP) was initially titrated by patient's tolerance . The noninvasive ventilation lasted at least 20 minutes until the breathing was stable. All the raw signals were recorded. The last 15 minutes of the stable computer-stored data were calculated and analyzed. The leaks were monitored by the display of the ventilator and the computer during the procedure. When the leak was observed, the mask was carefully adjusted to prevent. Esophageal and gastric balloon-catheters were used to detect the intra-thoracic and abdominal pressure. Airway pressure was also measured simultaneously. EMGdi was recorded from a multipair esophageal electrode .During ventilation Airflow and ventilation were measured with pneumotachograph.

Respiratory rate, tidal volume,the time difference between the initial increase and the termination of the diaphragm electromyogram(EMGdi) , time difference between maximal value of EMGdi and the end of inspiratory flow,time difference between the point of zero flow between inspiration and expiration ,and the time difference between the onset of the upward deflection in transdiagramic pressure( Pdi) and the return of Pdi were calculated during the unassisted spontaneous breathing and mechanical ventilation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •chronic obstructive pulmonary disease patient meet the diagnose criteria of chronic obstructive pulmonary disease
  • •interstitial lung disease patient meet the diagnose criteria of interstitial lung disease
  • •healthy subjects No history of the lung and Cardiovascular disease.The lung function is normal.

排除标准

  • •severe Cardiovascular disease
  • •neuromuscular and chest wall deformity
  • •Respiratory arrest
  • •Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
  • •Change in mental status; uncooperative patient
  • •High aspiration risk
  • •Viscous or copious secretions
  • •Recent facial or gastroesophageal surgery
  • •Craniofacial trauma
  • •Fixed nasopharyngeal abnormalities
  • •Extreme obesity

研究组 & 干预措施

noninvasive mechanical ventilation

Experimental

To investigate the change of the neural inspiratory time and expiratory delay noninvasive mechanical ventilation ,in comparison to spontaneous breathing

干预措施: noninvasive mechanical ventilation (Device)

结局指标

主要结局

neural inspiratory time

时间窗: 20-30 minutes

Compare the neural inspiratory time during spontaneous breathing and noninvasive mechanical ventilation.

次要结局

  • expiratory delay(20-30 minutes)

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Jianheng

Dr

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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