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临床试验/NCT05480748
NCT05480748已完成不适用

Oxygen Reserve Index in Predicting Hypoxemia in Morbidly 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 51 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

研究概览

简要总结

After obtaining the approval of the hospital ethics committee, this prospective, observational study included written informed consent from 51 participants with 19<BMI<25 m/kg2 and 51 participants with BMI>40 m/kg2 undergoing an elective surgical requiring endotracheal intubation. In addition to standard monitors, an oxygen reserve index (ORI) sensor was placed and baseline values were recorded. The participants were preoxygenated until end expiratory oxygen concentration (EtO2) is reached 90%. After anesthesia induction and endotracheal intubation, the breathing circuit was not connected endotracheal tube until the peripheral oxygen saturation (SpO2) decreased until 95%.ORİ and SpO2 values were continuously recorded. Time of tolerable apnea, ORI warning, SpO2 warning and added warning were also recorded.

详细描述

This single-center prospective, observational study was approved by Institutional Ethics Committee (Decision No:2022/514/222/9, Date:30/03/2022) and was performed in accordance with the Declaration of Helsinki. Written, informed consent was obtained from 51 participants with BMI>40 kg/m2(morbidly obesity) and 51 participants with19<BMI<25 kg/m2(normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation. Participants with significant history of cardiopulmonary disease, 25<BMI<40 kg m2, ASA>4 and<18 years of age, difficult intubation, pregnancy, hemoglobinopathies and preoperative hemoglobin of less than 10.0 mg/dL were defined as exclusion criteria.

Standard monitors were routinely established for each participants, including heart rate (HR), noninvasive blood pressure measurements. In addition, an ORi and SpO2 were measured simultaneously at 1-s interval with a pulse oximetry sensor (Rainbow sensor, R2-25) applied to the finger and connected to a Masimo Root with Radical-7 pulse oximeter (Masimo Corp.) Data for analysis was downloaded from the Root monitor.

Following the placement of monitors, baseline values were recorded. Participants were then preoxygenated with spontaneous ventilation and 100% inspirative oxygen concentrate (FiO2) at a flow rate of 8 liter/minute via a tight-fitting face mask until EtO2 is reached to 90%. Anesthesia was induced with intravenous midazolam, fentanyl, propofol and rocuronium in 100% FiO2.The trachea was intubated after 3-4 minutes under direct visualization using a videolaryngoscope to confirm placement.The endotracheal tube was not connected to the breathing circuit, and the participants remained apneic. The World Health Organization defines intraoperative SpO2 ≥ 95% as normal in its training materials, and treatment steps are mentioned for SpO2 ≤ 94% [12]. However, since we included morbidly obese participants with limited functional residual capacities in our study and wanted to stay with in the safe range, we allowed SpO2 to decrease up to 95%. At the same time, the alarm point for SpO2 is applied as 95% in our clinic's protocol for morbidly obese patients.

ORi and SpO2 values were recorded continuously. Subsequently, the anesthesia circuit was connected and patients were ventilated with 100% Fraction of Inspired Oxygen ( FiO2), tidal volume targeted 7 ml/kg and 5 cmH2O of positive end-expiratory pressure until ORi plateaued.Thereafter, anesthesia continued per routine.

ORi and SpO2 data were compared at five specific time points: 1) baseline; 2) at the end of pre-oxygenation when the EtO2 reaches to 90%; 3) at the beginning of intubation; 4) when SpO2 reaches 95%; and 6) during ventilation with 100% FiO2 when the ORi reaches a plateau.

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

  • 18-75 years,
  • BMI>40 kg/m2 (morbidly obesity)
  • 19<BMI<25 kg/m2 ,
  • Elective surgical procedure requiring general anesthesia with endotracheal intubation

排除标准

  • History of cardiopulmonary disease,
  • 25<BMI<40 kg m2,
  • <18 years of age,
  • Difficult intubation,
  • Pregnancy,
  • Hemoglobinopathies
  • Preoperative hemoglobin of less than 10.0 mg/dL

结局指标

主要结局

In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

时间窗: 'Time until ORI reaches to 0.24 (It is evaluated in the first 15 minutes after the patient is given anesthesia)

Primary endpoint; To evaluate whether ORi provides an earlier, more relevant clinical warning of impending desaturation compared to pulse oximetry in morbidly obese patients.

次要结局

  • In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.(Time from intubation until SpO2 drops to 95% (until 30 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

Assoc Dr

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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