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临床试验/NCT04872361
NCT04872361Unknown不适用

Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies

Mansoura University2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
117
试验地点
2
主要终点
Pre-emergence LUS score

研究概览

简要总结

Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.

Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

详细描述

The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.

Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.

A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography

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
Double (Participant, Outcomes Assessor)

盲法说明

Double-blind (Participant, Outcomes Assessor).

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists' physical status grades I, II, and III.

排除标准

  • Patient refusal.
  • Psychiatric diseases.
  • Body Mass Index > 35 Kg/m
  • Previous intrathoracic procedures.
  • History of severe obstructive pulmonary disease.
  • History of severe restrictive lung disease.
  • Pulmonary arterial hypertension ( systolic pulmonary arterial pressure >40 mmHg).
  • Pregnancy.

结局指标

主要结局

Pre-emergence LUS score

时间窗: intraoperative before recovery from anesthesia

Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.

次要结局

  • Lung ultrasonography score (LUS score)(preoperative, intraoperative for anesthesia duration to 1 hour postoperative)
  • Heart rate(preoperative, intraoperative for anesthesia duration to 1 hour postoperative)
  • End-tidal carbon dioxide tension(intraoperative for anesthesia duration)
  • PaO2/FiO2(Intraoperative and 15 min postoperative)
  • Mean blood pressure(preoperative, intraoperative to 1 hour postoperative)
  • Arterial partial pressure of carbon dioxide (PaCO2)(Intraoperative and 15 min postoperative)
  • Postoperative pulmonary complications (PPCs)(5 days)
  • oxygen saturation(preoperative, intraoperative to 1 hour postoperative)
  • Arterial partial pressure of oxygen (PaO2)(Intraoperative and 15 min postoperative)
  • Peak inspiratory pressure(intraoperative for anesthesia duration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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