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临床试验/NCT04507295
NCT04507295Unknown不适用

the Effect of Different Modes of Mechanical Ventilation on Cerebral Blood Flow During Thoracoscopic Surgeries in Neonates (RCT)

Cairo University0 个研究点目标入组 30 人开始时间: 2020年8月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
cerebral saturation

研究概览

简要总结

the aim of this study is to compare the effect of different modes of mechanical ventilation by using volume-controlled ventilation and pressure-controlled ventilation on cerebral blood flow monitored by cerebral oximetry during thoracoscopic surgeries in neonates.

详细描述

The brain uses aerobic metabolism exclusively for energy production, so the brain is critically dependent on the nearly continuous delivery of oxygen to maintain cellular energy production. Normal cerebral blood flow is approximately 50 ml/100 gram of brain tissue/min. The brain represents 2% of the total body weight but it receives about 15% of the cardiac output. The brain is supplied by the circle of Willis which is formed of anastomosis between the internal carotid artery and the vertebro-basillar system. Monitoring of the CBF depends on either assessing the blood flow itself (e.g, radioactive substance and transcranial duplex) or assessing the oxygen delivery to the brain (e.g, cerebral oximetry and jugular bulb venous O2 saturation). CBF monitoring is an important parameter in both Intensive care unit and operation room in several aspects e.g, traumatic brain injury (TBI), acute stroke, carotid artery surgeries and cardiopulmonary bypass.

Cerebral oximetry is a continuous noninvasive technique that monitors the cerebral blood flow with several advantages over other CBF monitors including the ease of use and interpretation. It is painless and does not utilize ionizing radiation. The recordings provide real time information rather than single static measurements. Using the cerebral oximetry has few limitations including representing local rather than global CBF and absence of normal and cutoff values.

Thoracoscopic surgery was first introduced in 1910 and allowed a major advance in the field of thoracic surgery. Then with the improvement of the Instrumentation, thoracoscopic surgery started in the pediatric field in 1976 for simple procedures and now it is used predominantly in the pediatric thoracic surgery. The use of thoracoscope has many advantages over the open approach including using a smaller incision and reducing blood loss, postoperative pain, hospital stay and musculoskeletal deformities. Thoracoscope utilizes either one lung ventilation (OLV) or CO2 insufflation technique. In neonates the OLV technique is not suitable, so CO2 insufflation ( capnothorax ) is usually used.

Several studies were done and revealed the effect of thoracoscopy in neonate on CBF due to the effect of capnothorax which increases the intrathoracic pressure leading to decreased venous return and cardiac output, subsequently the CBF decreases, and with the increase of the insufflation pressure the decease in the CBF becomes more significant. Also the capnothorax may lead to hypercapnia which leads to changes in the CBF.

The incidence of newborn with congenital anomalies that require surgical procedure during the neonatal period is not low. With the increase of the survival rate, several studies proved that exposure of the neonates to surgery and anesthesia is associated with a higher risk of neuro-developmental delay in different aspects (sensory, motor, language, behavioral, cognitive, etc.) and thoracoscopic surgery is associated with higher risk due to the nature of the disease and the surgery. Using cerebral oximetry in addition to other routine monitors is of added value to maintain CBF within normal range to decrease the incidence of neurological injuries.

研究设计

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

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • full term neonates
  • body weight more than 2500 gm

排除标准

  • parents' refusal
  • preterm neonates
  • body weight less than 2500 gm
  • congenital cardiac condition
  • active chest condition
  • congenital neurological diseases
  • abnormal kidney and liver function tests

结局指标

主要结局

cerebral saturation

时间窗: during the whole duration of surgery

the cerebral oxygen saturation ( % ) will be measured using the cerebral oximetry(INVOS 5100) and will be recorded before induction of anesthesia then every 15 minutes after induction of anesthesia and any attack of cerebral desaturation is recorded

次要结局

  • arterial partial pressure of carbon dioxide ( PaCO2 )(during the whole duration of surgery)
  • End Tidal CO2 ( ETCO2 )(during the whole duration of surgery)
  • Fraction of inspired oxygen(during the whole duration of surgery)
  • oxygen saturation ( SPO2 )(during the whole duration of surgery)
  • Positive End Expiratory Pressure ( PEEP )(during the whole duration of surgery)

研究者

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

Hussam Hassan

Doctor

Cairo University

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