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临床试验/NCT04002609
NCT04002609已完成不适用

The Systemic and Brain Oxygen Stauration Change During Bronchoscopy

University of Debrecen1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年6月30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
92
试验地点
1
主要终点
systemic oxygen saturation

研究概览

简要总结

Bronchofiberoscopy is a widespread invasive intervention in clinical practice with a number of diagnostic and therapeutic indications. The Clinic of Pulmonary Medicine in Debrecen carries out nearly 2000 examinations a year. The intervention is guided by the recommendation of the Vocational College for Pulmonary Medicine in 2005, but it does not contain a clear recommendation on the oxygen therapy used during the intervention. The Hungarian recommendation states that pulsoximetry is mandatory in bronchoscopy, but it does not contain information on the indications and the implementation of oxygen suplementation. The British Thoracic Society Guideline 2013 deals with the issue and makes the following statements:

  • patients should be monitored for oxygen saturation under bronchofiberoscopy
  • oxygen supplementation during the test is recommended if the patient's desaturation is significant (greater than 4% or less than 90%) and is over 1 minute
  • during the bronchoscopy, the occurrence of oxygen saturation decreases depending on the level of initial oxygen saturation, respiratory function, co-morbidity, sedation and the course of intervention.

The aim of our study is to investigate the frequency with which systemic hypoxia occurs during bronchoscopy, what factors may contribute to its development and how the level of cerebral oxygen saturation changes with systemic desaturation (in the case of NIRS, a 20% reduction from baseline is considered significant).

详细描述

: Consecutive patients admitted to Bronchology Laboratory of Department of Pulmonology, University of Debrecen for flexible bronchoscopy were asked to participate in the study. After explaining the procedure in detail, all patients gave written informed consent.

The indication of flexible bronchoscopy was based in all cases on the results of medical history, physical examination, chest X-ray and/or chest CT scan, lung function tests and laboratory parameters including hemoglobin concentration, hemostasis variables as well as blood gas analysis when necessary.

Bronchoscopy (PENTAX EB-1975K) was performed after an at least 4-hour fasting period. The procedure was performed either in sitting or supine position after a topical administration of lidocaine 2% solution. Routine monitoring consisted of ECG, non-invasive blood pressure measurement, pulse oxymetry (finger probe). As an additional monitoring tool, near infrared monitoring sensor was placed to the forhead of the dominant hemisphere of patients for monitoring cerebral oxygen saturation. INVOS 5100 C cerebral oximeter (Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA) was used for cerebral near infrared spectroscopy measurements.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • inclusion criteria: adult patients (over 18 years) going elective bronchoscopy

排除标准

  • age under 18 years

结局指标

主要结局

systemic oxygen saturation

时间窗: during bronchoscopy

measure systemic oxygen saturations with Infinity Delta XL

次要结局

  • cerebral oxygen saturation(during bronchoscopy)

研究者

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

Tamas Vegh, MD

Head, Division of General, Vascular and Thoracic Anesthesia

University of Debrecen

研究点 (1)

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