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临床试验/NCT03637530
NCT03637530Unknown不适用

A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery

All India Institute of Medical Sciences, Rishikesh0 个研究点目标入组 128 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
128
主要终点
change in partial pressure of oxygen from baseline

研究概览

简要总结

Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. In turn it will be associated with increase in peak and plateau airway pressure during positive pressure ventilation. Inverse ratio ventilation has been shown to improve lung compliance and restrict the peak and plateau airway pressure and should be useful as one of the lung protective ventilation method to improve respiratory outcome in laparoscopy surgery.

详细描述

Anaesthesiologists have been ventilating patients in the perioperative period with relatively large tidal volumes (10-15 ml/kg ideal body weight) to prevent intraoperative atelectasis. Ventilating patient with large tidal volumes may be a risk factor for development of lung injury.During surgical procedures, both general anesthesia and high tidal volumes may strain non injured lungs and trigger inflammation. High tidal volumes that cause alveolar overstretching can contribute to extra pulmonary organ dysfunction through systemic release of inflammatory mediators.

Recently protective lung ventilation strategies has been reported to be useful to reduce the respiratory complications in postoperative period. The use of small tidal volume (Vt), positive end-expiratory pressure (PEEP) and restricting peak airway pressure have shown reduced incidence of ventilation induced lung injury.

It has been shown that a small tidal volume (VT) and PEEP can reduce the incidence of postoperative lung dysfunction and improve intraoperative oxygenation. Restricting peak airway pressure can be achieved by inverse ratio ventilation. Minimizing the risk of ventilator-induced lung injury (VILI), improving oxygenation and alveolar recruitment are all advantages of inverse ratio ventilation. However, the potential utility of pressure controlled inverse ratio ventilation (PCIRV) has not been studied in patients undergoing general anaesthesia.

Investigators hypothesized that in patients with normal lungs scheduled for general anesthesia, PIV might prevent lung function deterioration and lung morphological alterations. Investiagators aim was to compare the intraoperative protective ventilation strategies on oxygenation/ ventilation and postoperative lung dysfunction and lung injury among patients undergoing laparoscopic upper abdominal surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-60 years
  • •ASA- I and II
  • •Patients undergoing laparoscopic upper abdominal surgery

排除标准

  • •Significant pulmonary disease
  • •Significant cardiac dysfunction
  • •BMI>30 kg/m2

研究组 & 干预措施

intervention group

Experimental

in this group of patients, inverse ratio ventilation is provided during general anaesthesia

干预措施: inverse ratio ventilation (Other)

control group

No Intervention

in this group of patients, conventional ventilation is provided during general anaesthesia

结局指标

主要结局

change in partial pressure of oxygen from baseline

时间窗: upto 1 day postoperatively

Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures

次要结局

  • changes in pulmonary function tests from baseline(upto 3 days postoperatively)

研究者

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

ADABALA VIJAY BABU

post graduate,department of Anesthesiology,AIIMS Rishikesh

All India Institute of Medical Sciences, Rishikesh

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