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临床试验/NCT01514331
NCT01514331已完成不适用

Determination of Ventilatory Parameters and Inflammatory Responses of Neonates Who Are Ventilated by Volume Guarantee Combined With Synchronized Intermittent Mandatory Ventilation or Pressure Support Ventilation

Gazi University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年1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
入组人数
40
试验地点
1
主要终点
IL-1beta levels in tracheal aspirate material

研究概览

简要总结

The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.

详细描述

Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates.

From past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold).

Since there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols.

Literature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
— 至 24 Hours(Child)
性别
All
接受健康志愿者
否

入选标准

  • •neonates with respiratory distress who need mechanical ventilation
  • •gestational age less than or equal to 37 weeks
  • •neonates who need mechanical ventilation within first 24 hours

排除标准

  • •neonates who need mechanical ventilation other than conventional ventilation

研究组 & 干预措施

PSV+VG

Active Comparator

Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode

干预措施: PSV+VG (pressure support ventilation+volume guarantee) (Other)

SIMV+VG

Active Comparator

Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode

干预措施: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee) (Other)

结局指标

主要结局

IL-1beta levels in tracheal aspirate material

时间窗: Baseline and 72 hours of mechanical ventilation

Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

IL-6 level in tracheal aspirate

时间窗: Baseline and 72 hours of mechanical ventilation

Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported

IL-8 in tracheal aspirate material

时间窗: Baseline and 72 hours of mechanical ventilation

Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

IL-10 level in tracheal aspirate material

时间窗: Baseline and 72 hours of mechanical ventilation

Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

TNF alfa in tracheal aspirate material

时间窗: Baseline and 72 hours of mechanical ventilation

Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported

oxygen saturation variability

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

changes in oxygen saturation, desaturation rate, hyperoxy rate

lowest carbondioxide level (mmHg)

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

ratio of hypocarbic blood gases and least pCo2 level

highest carbondioxide level (mmHg)

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

ratio of hypercarbic blood gases and highest pCo2 level

highest oxygen level (mmHg)

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

ratio of hyperoxic blood gases and highest pO2 level

tidal volume variability

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

variability in tidal volume measured with babyview program

respiratory rate variability

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

changes in respiratory rate, tacypnea rate

peak inspiratory pressure variability

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

variability in peak inspiratory pressure measured with babyview program

lowest oxygen level (mmHg)

时间窗: 72 hours of mechanical ventilation or entire ventilation time if extubated earlier

ratio of hypoxic blood gases and least pO2 level

次要结局

  • bronchopulmonary dysplasia(36 weeks corrected age)
  • patent ductus arteriosus(in the first week of post natal life of the patient)
  • necrotizing enterocolitis(36 weeks corrected age)
  • intraventricular hemorrhage(during first week)
  • pneumothorax(during first 3 days)
  • pulmonary interstitial emphysema(during first week)
  • pulmonary hemorrhage(during first week)
  • retinopathy of prematurity(until 36 weeks corrected age)

研究者

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

Ebru Ergenekon

Prof.Dr

Gazi University

研究点 (1)

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