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临床试验/NCT03278795
NCT03278795Unknown不适用

Volume Support Ventilation Versus Pressure Support Ventilation as a Weaning Mode of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Success rate

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. Acute exacerbations may occur during the management of stable COPD which can negatively impact health status, rates of hospitalization and re-admission. During exacerbation, some patients need immediate admission to the respiratory intensive care unit (RICU) for ventilatory support. As prolonged mechanical ventilation has unfavourable impacts, it is Important to minimize the duration of mechanical ventilation and perform extubation as soon as possible. In recent years, development of numerous models of artificial respiration, which could support spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory support. From these new modes, PSV which is a well known weaning mode will be compared in our study to a new weaning mode which is a volume support ventilation (VSV).

详细描述

Acute exacerbations may occur during the management of stable COPD which can negatively impact health status, rates of hospitalization and re-admission. During exacerbation, some patients need immediate admission to the respiratory intensive care unit (RICU). Ventilatory support in an exacerbation can be provided by either noninvasive (nasal or facial mask) or invasive (oro-tracheal tube or tracheostomy) ventilation.

Mechanical ventilation may be complicated by barotrauma, volutrauma, and also unfavourable impacts on cardiovascular system and organ perfusion. Moreover, prolonged mechanical ventilation enhances the risk of nosocomial pneumonia. So it is Important to minimize the duration of mechanical ventilation and perform extubation as soon as possible. In recent years, development of numerous models of artificial respiration, which could support spontaneous breathing, has made it possible to gradually decrease the mechanical ventilatory support.

From these new modes, PSV (pressure-support ventilation) which is a well known weaning mode will be compared in our study to a new weaning mode which is a volume support ventilation (VSV).

VSV could be viewed as "PRVC for spontaneous breathing" as it delivers a variable pressure to meet a target VT.

  • The ventilator gives a test breath with an inspiratory pressure of 10 cmH2O above PEEP (5 cmH2O in earlier software versions)
  • It measures the volume delivered and calculates system Compliance
  • For each subsequent breath, the ventilator calculates compliance of the previous breath and adjusts the inspiratory pressure level (pressure level) to achieve the set VT on the next breath
  • The ventilator will not change the inspiratory pressure by more than 3 cm H2O from one breath to the next
  • Maximum available inspiratory pressure level is 5 cm H2O below the preset upper pressure limit (alarm will sound at this point and the breath will switch into exhalation)
  • The minimum pressure limit is the baseline setting (PEEP)
  • If apnea occurs, back up pressure control is activated and an alarm sounds
  • If Auto mode is on and patient becomes apneic, the mode will automatically switch to PRVC(pressure regulated volume control).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • All mechanically ventilated COPD patients at RICU.

排除标准

  • COPD patients associated bronchiectasis , interstitial lung disease and pneumonia.
  • Neurological and neuromuscular diseases hindering the respiratory drive.

研究组 & 干预措施

PSV mode

Active Comparator

PSV weaning group

干预措施: pressure support ventilation mode (Procedure)

VSV mode

Experimental

VSV weaning group

干预措施: volume support ventilation mode (Procedure)

结局指标

主要结局

Success rate

时间窗: the first 48 hours after ex-tubation from mechanical ventilation .

Assess success rate of PSV and VSV in weaning of COPD patients .Weaning success is defined as extubation and the absence of ventilatory support 48h following the extubation .

次要结局

  • Number of weaning trials(the first 48 hours after ex-tubation from mechanical ventilation .)
  • Detection of response to both modes(the first 48 hours after ex-tubation from mechanical ventilation .)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohammed Taghyan

Principal Investigator

Assiut University

研究点 (2)

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