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临床试验/CTRI/2022/11/047449
CTRI/2022/11/047449尚未招募不适用

Intraoperative Lung-protective ventilation strategy for patients undergoing open Abdominal surgeries in Trendelenburg position: A Randomized Controlled Trial

NIMS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMS
入组人数
60
试验地点
1
主要终点
intra- and postoperative changes in P/F.

研究概览

简要总结

Extreme steep Trendelenburg position of 25-40 degrees could contribute to Atelectasis formation, particularly in dependent regions and elevate mechanical stress in pulmonary parenchyma, triggering significant perioperative pulmonary dysfunction. Administration of General Anesthesia further decreases the End -Expiratory lung volume (EELV) forming Atelectasis and leads to a deterioration in respiratory mechanics and gas exchange. Ventilation strategy employing high tidal volumes could over distend normal lungs, thereby activating a local inflammatory reaction. Furthermore , zero- positive end-expiratory pressure or low levels of positive end-expiratory pressure (PEEP) could induce repetitive collapse and reopening of Alveoli, which ultimately result in an inflammatory injury. In recent years , intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator- induced lung injuries  (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP and recruitment maneuvers (RMs). In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI) by employing a low tidal volume (Vt), an appropriate level of PEEP , and recruitment maneuvers (RMs) .The goals of these interventions are to minimize alveolar over distention, to prevent repeated collapse and reopening of alveoli and to reduce atelectasis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with 18-65years of age 2.either gender
  • patients undergoing elective open abdominal surgeries in trendelenburg position 4.surgery duration of greater than 2hours 5.American Society of Anesthesiologists (ASA) physical status I,II,III .

排除标准

  • 1.Refusal to participate in the study 2.Preexisting significant cardiac or pulmonary co morbidities (heart failure, intractable shock, Chronic obstructive pulmonary disease, Asthma, pulmonary infection, bronchiectasis, pulmonary metastases) 3.Preexisting abnormalities on chest X-ray or spirometry.
  • 4.History of neuromuscular disease 5.Liver cirrhosis (Child B or C), or chronic renal failure with hemodialysis, and the 6.Need to continue prolonged mechanical ventilation after surgery.

结局指标

主要结局

intra- and postoperative changes in P/F.

时间窗: intra- and postoperative changes in P/F, PaO2 before induction, 1hour after intubation and postoperative day 1

次要结局

  • differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat, and the incidence of atelectasis detected on chest x-ray on the first postoperative day.(differences between the two groups regarding PaO2, A-aO2; intraoperative Cdyn and Stat after intubation,30min after intubation,60min before extubation and at extubation, and the incidence of atelectasis detected on chest x-ray on the first postoperative day.)

研究者

发起方
NIMS
申办方类型
Research institution and hospital

研究点 (1)

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