跳至主要内容
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2024年8月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hyperoxia
发起方
Kocaeli University
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).
状态
已完成
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2024年8月29日
结束日期
2026年3月6日
最后更新
上个月
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Volkan Alparslan

Asist. Prof. M.D

Kocaeli University

入排标准

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.

研究点 (1)

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