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临床试验/NCT06307704
NCT06307704进行中(未招募)不适用

Intraoperative Bedside Lung-ultrasound Use to Optimize Positive End-expiratory Pressure for Elective Robotic-assisted Radical Prostatectomy or Cystectomy Patients: a Randomized Controlled Trial

Nazmy Edward Seif1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
88
试验地点
1
主要终点
Post-operative lung consolidation

研究概览

简要总结

There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).

Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.

Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.

The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I, II & III.
  • Normal respiratory functions or mild lung disease.

排除标准

  • BMI more than
  • Moderate to severe obstructive pulmonary disease (FEV1 < 80% of predicted).
  • Moderate to severe restrictive pulmonary disease (TLC < 70% of predicted).
  • Severe pulmonary hypertension (mean PAP>55).
  • Previous lung surgery.
  • Decompensated cardiac disease (NYHA 3 or 4).
  • Patients who received invasive mechanical ventilation within the last 30 days before surgery.

研究组 & 干预措施

US - PEEP group

Experimental

Lung Ultrasound - guided Positive End Expiratory Pressure group

干预措施: Lung Ultrasound - guided Stepwise PEEP (Procedure)

US - PEEP group

Experimental

Lung Ultrasound - guided Positive End Expiratory Pressure group

干预措施: Standard Ventilation Protocol (Procedure)

Standard group

Active Comparator

Standard Ventilation group

干预措施: Standard Ventilation Protocol (Procedure)

结局指标

主要结局

Post-operative lung consolidation

时间窗: 24 hours

Presence (or not) of post-operative lung consolidation detected by lung ultrasound.

次要结局

未报告次要终点

研究者

发起方
Nazmy Edward Seif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nazmy Edward Seif

Clinical Professor

Cairo University

研究点 (1)

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