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临床试验/NCT06430606
NCT06430606进行中(未招募)不适用

How Do Novel Oxygenation Indices Change With Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries?

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
42
试验地点
1
主要终点
Oxygenation indices

研究概览

简要总结

In this study, changes in new oxygenation indices investigated by Asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and Trendelenburg position.

详细描述

During the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. The PaO2/FiO2 and SpO2/FiO2 ratios have been traditionally used to assess this condition. Subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (OI = (FiO2 × Pmean) / PaO2) and oxygenation saturation index (OSI = (FiO2 × Pmean) / SpO2). More recently, Asar et al. have defined 8 novel oxygenation indices using mean power (MP) and driving pressure (DP) instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). They compared the predictive power of these new indices for intensive care unit (ICU) mortality in COVID-ARDS (C-ARDS) patients with conventional oxygenation indices (PaO2/FiO2, SpO2/FiO2, OI, OSI). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices were found to have the highest predictive power for ICU mortality. However, there is currently no study investigating the changes of these new indices during the intraoperative period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists) class I-III
  • Age between 18-75 years
  • Signed informed consent form

排除标准

  • Diagnosis of COPD (Chronic Obstructive Pulmonary Disease) and asthma
  • History of thoracic surgery
  • Body mass index (BMI) > 35
  • Development of hemodynamic instability or desaturation (SpO2 < 92) during the operation

结局指标

主要结局

Oxygenation indices

时间窗: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI (oxygenation saturation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

次要结局

  • Arterial blood gas parameters(during the surgery and immediately after the surgery (approximately 3 hours to 6 hours))
  • Mechanical ventilator parameters(during the surgery and immediately after the surgery (approximately 3 hours to 6 hours))
  • Hemodynamic parameters(during the surgery and immediately after the surgery (approximately 3 hours to 6 hours))

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Furkan Tontu

Doctor of Anesthesiology and Reanimation

Başakşehir Çam & Sakura City Hospital

研究点 (1)

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