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临床试验/CTRI/2017/11/010592
CTRI/2017/11/010592已完成不适用

Pressure controlled ventilation with 5 vs 10 cm H2O in children undergoing laparoscopic surgery

Department of Anaesthesia Intensive Care PGIMER1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Compare and assess the effect of 5 & 10 cm H2O PEEP on oxygenation in children undergoing laparoscopic procedures under GA

研究概览

简要总结

In recent times laparoscopic surgery has become the treatment modality of choice not only in adults but also in paediatric patients. Creation of carbon dioxide Pneumoperitoneum (Pnp)is an essential component of laparoscopic procedures.Increased intra abdominal pressure due to Pnp causes splinting and cephalad shift of diaphragm , which leads to absolute decrease in functional residual capacity, atelectasis , decreased lung compliance and increased ventilation perfusion mismatch.In paediatric patients due to small airway calibre, increased dead space ventilation there is increase chance of  hypercarbia , acidosis and relative hypoxia.

Pressure Controlled Ventilation uses a decelerating flow , which compensate any potential reduction in ventilation. it enables more homogenous distribution of tidal volume in all ventilated alveoli reducing the amount of atelectasis by an improved alveolar recruitment.The patients receives an appropriate volume independent of circuit compliance and nd changes in fresh gas flow/ leaks around endotracheal tube.

Positive End Expiratory Pressure [PEEP] has been used to attenuate the fall in partial pressure of arterial oxygen that accompanies Pnp. The use of PEEP prevents alveolar atelectasis and cyclical recruitment ,improving lung compliance and correcting  ventilation perfusion mismatch. There is no consensus regarding  the ideal level of PEEP during laparoscopic surgery.

A study suggested that  in adult laparoscopic cholecystectomy, application of 10 cm H2O PEEP during Pnp increases compliance and oxygenation, does not cause hemodynamic and respiratory complicationsand reduces the post operative stress response in comparison to external PEEP OF 5 cm H2O. NO  comparison of various level of PEEP has been evaluated in children.Therefore the  aim of the present study is to compare and asses the effect of 5 and 10 PEEP on oxygenation , ventilation and hemodynamic parameters in children undergoing laparoscopic procedures under general anaesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • children of age 2 to 10 years and ASA physical status I or II undergoing laparoscopic procedures under general anaesthesia.

排除标准

  • Children with predicted difficult intubation and ventilation Acute respiratory tract infection Severe/active cardiopulmonary disease Previous H/O or family H/O malignant hyperthermia.

结局指标

主要结局

Compare and assess the effect of 5 & 10 cm H2O PEEP on oxygenation in children undergoing laparoscopic procedures under GA

时间窗: T1: Baseline value with the patient in the supine position 2 minutes after tracheal intubation and stabilization on the ventilator. | T2: 2 minutes after insufflating CO2 to an intra-abdominal pressure of 12 mmHg. | T3: 1 hour After applying PEEP 5 or 10cm H20. | T4: After completing the surgical procedure with the patient returned to the supine position with the abdomen deflated

次要结局

  • Compare and assess the effect of 5 & 10 cm H2O PEEP on ventilation and hemodynamicparameters in children undergoing laparoscopic procedures under GA

研究者

发起方
Department of Anaesthesia Intensive Care PGIMER
申办方类型
Government medical college

研究点 (1)

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