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临床试验/NCT06404151
NCT06404151招募中不适用

Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation in Determining Hypoxia in Obese Patients

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

研究概览

简要总结

The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients who are sensitive to hypoxia. Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.

详细描述

Standard noninvasive monitoring will be applied to the patients taken to the operating table, and heart rate, mean arterial pressure, peripheral oxygen saturation (SpO2), oxygen reserve index (ORI), regional cerebral oxygen saturation, etCO2 values will be recorded. Cerebral oximeter probe placed in the middle of the forehead (every second Cerebral oxygen saturation will be continuously monitored using a rcSO2 reading) (Massimo)Preoxygenation will be performed until the expiratory O2 concentration is 90% (during spontaneous ventilation, FIO2 will be kept between 100% 6 lt7min flow rate and EtCO2 30-35 mmHg). 2 mg midazolam, 2 ug General anesthesia with /kg fentanyl, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 100% O2 will be applied and intubated with a videolaryngoscope. The breathing circuit will be disconnected from the endotracheal tube until the SpO2 drops to 94%. At that time, the breathing circuit will be connected and the patients will be ventilated with 100% FiO2, 8 ml kg-1 ideal body weight, targeted tidal volume, and 5 cm H2O positive end-expiratory pressure until the ORI plateaus. Throughout this process, ORI and cerebral oxygen saturation will be recorded continuously. ORI and rcO2 data will be compared at seven specific time points ( (1) during the basal period; (2) at the end of preoxygenation when ORI reaches a plateau; (3) at the beginning of intubation; (4) when SpO2 reaches 97%; (5) when SpO2 reaches 94% (6) ORI reaches a plateau again (during ventilation with 100% FiO2), and (7) SpO2 reaches baseline

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 I-III patients
  • The ages of 18-75
  • Obese BMI (40>BMI>30 kgm^2)
  • Undergoing intubated elective surgery

排除标准

  • Patients with significant cardiopulmonary comorbidities
  • BMI>40 kgm^2 and BMI<30 kg m^2
  • Patients under 18 years and over 75 years of age

结局指标

主要结局

Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

时间窗: after intubation time until spO2 reaches to 97% and 94% and ori reaches to the plato.Expected to take approximately five minutes

The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients (BMI 30-40 kg/m\^2) (weight and height will be combined to report BMI in kg/m\^2)

次要结局

  • Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients(time until spo2 is 94% and 97% and ori reaches to the plato.Expected to take approximately five minutes)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gülten Arslan

assos prof

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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