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临床试验/NCT06566690
NCT06566690已完成不适用

Association Between Sensory Block Level, Oxygen Therapy, and ORi in Varicose Vein Patients Undergoing Spinal Anesthesia: A Correlation Study

Kocaeli University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
The primary outcome of this study is to assess the correlation between the need for oxygen therapy, the ascension of sensory block level, and changes in Oxygen Reserve Index (ORi).

研究概览

简要总结

The assessment of peripheral capillary oxygen saturation (SpO2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. The oxygen reserve index (ORI) can provide an early warning of deteriorating oxygenation long before a change in SpO2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. The combination of ORI with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. In spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. Therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. The investigators wanted to investigate the correlation between ORI, SpO2, oxygen therapy and the degree of sensory block.

详细描述

The assessment of peripheral capillary oxygen saturation (SpO2) by pulse oximetry has become standard in perioperative care for the detection of hypoxaemia. The oxygen reserve index (ORI) can provide an early warning of deteriorating oxygenation long before a change in SpO2 occurs, reflect the response to oxygen administration, facilitate oxygen titration and prevent unwanted hyperoxia. The combination of ORI with pulse oximetry can help to accurately adjust inhaled oxygen concentration and prevent hypo- and hyperoxaemia. In spinal anaesthesia, neuraxial blockade can cause paralysis of accessory respiratory muscles and theoretically lead to bronchospasm. The respiratory effects of neuraxial blockade up to mid-thoracic level are minimal in patients without lung disease. While the intercostal muscles may be paralysed by thoracic block, diaphragmatic function is preserved. Therefore, in this study, the investigators planned to perform oxygen saturation monitoring using two modalities. The investigators wanted to investigate the correlation between ORI, SpO2, oxygen therapy and the degree of sensory block.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - ASA I-II

排除标准

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Smoking history of >30 pack-years
  • Cancer patients
  • Interstitial lung disease patients
  • Patients with Body Mass Index (BMI) >30 kg/m²
  • Patient refusal of spinal anesthesia
  • Refusal to participate in the study

结局指标

主要结局

The primary outcome of this study is to assess the correlation between the need for oxygen therapy, the ascension of sensory block level, and changes in Oxygen Reserve Index (ORi).

时间窗: 9 months

The primary outcome measure of this study is to evaluate the potential correlation between three variables: the need for supplemental oxygen therapy, the cephalad progression of sensory block level, and fluctuations in oxygen reserve index (ORi) values.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Volkan Alparslan

Asist. Prof. M.D

Kocaeli University

研究点 (1)

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