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临床试验/NCT07722052
NCT07722052已完成不适用

Diaphragmatic Ultrasound and Spirometry After Ultrasound-guided Stellate Ganglion Block: a Prospective Observational Study

Jose Manuel López González1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年12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
15
试验地点
1
主要终点
Diaphragmatic excursion

研究概览

简要总结

The objective of our study was to evaluate the incidence of hemidiaphragmatic paralysis after ultrasound-guided stellate ganglion block (US-SGB) by assessing diaphragmatic excursion and diaphragmatic thickening fraction using diaphragm ultrasound.

详细描述

A prospective, single-center observational study was designed with the aim of evaluating diaphragmatic excursion and diaphragmatic thickening fraction, measured by ultrasound before and 30 minutes after US-SGB performed with 10 mL of 0.25% levobupivacaíne.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • patients over 18 years of age.
  • patients with sympathetic nervous system-mediated disorders.

排除标准

  • patients younger than 18 years of age.
  • patients with severe chronic obstructive pulmonary disease.
  • previous diaphragmatic paralysis or neuromuscular disease.
  • inability to undergo diaphragmatic ultrasound.
  • patients with neck anatomy considered unsuitable for the procedure (including previous neck surgery, burns, extensive scarring or large goiters resulting in distortion of normal cervical anatomy).
  • contraindications to the interventional technique (such as infection at the puncture site, or refusal to provide consent).

结局指标

主要结局

Diaphragmatic excursion

时间窗: The diaphragmatic excursion, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.

Excursion of the diaphragmatic dome was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Once the dome was identified, excursion was measured in M-mode as the distance, in centimeters, between the end-expiratory and end-inspiratory positions during a vital capacity manoeuvre.

Diaphragmatic thickening fraction

时间窗: The diaphragmatic thickening, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.

The diaphragmatic thickening fraction was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Diaphragm thickness was measured, in centimeters, at end-inspiration and end-expiration during a vital capacity manoeuvre. Thickening fraction was calculated using the following formula and expressed as a percentaje: Thickening fraction = \[(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration\] x 100.

次要结局

  • Forced vital capacity (FVC)(Spirometric parameters measured at baseline and 1 hour after US-SGB.)
  • Forced expiratory volume in 1 second (FEV1)(Spirometric parameters measured at baseline and 1 hour after US-SGB.)
  • Tiffeneau index (FEV1/FVC ratio)(Spirometric parameters measured at baseline and 1 hour after US-SGB.)
  • Peripheral oxygen saturation (SpO2)(Measured at baseline and 1 hour after US-SGB.)

研究者

发起方
Jose Manuel López González
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Manuel López González

MD. Consultant Anesthesiologist and Pain Physician

Fundación para la Investigación Biosanitaria del Principado de Asturias

研究点 (1)

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