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临床试验/NCT03688724
NCT03688724已完成不适用

Perioperative Diaphragm Point-of-care Ultrasound (D-POCUS) for the Detection of Blockage and the Prediction of Postoperative Ventilatory Failure in Patients Who Received Brachial Plexus Blockages Above the Clavicle

Hospital General Universitario de Valencia1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年10月15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
65
试验地点
1
主要终点
Contralateral Diaphragm function change

研究概览

简要总结

It is a prospective observational study of a cohort of patients who underwent brachial plexus blockage above the clavicle, and in which diaphragmatic function is observed in both hemidiaphragms by ultrasound (using Diaphragm Thickening Fraction), which allows to obtain the real incidence of Hemidiaphragm palsy in these patients, and estimate the perioperative evolution of both hemidiaphragms.

Hemidiaphragm palsy after brachial plexus block above the clavicle (BPBAC) is frequent, but few patients develop postoperative pulmonary complications (PPC). Little attention has been paid to the contralateral hemidiaphragm as part of the global diaphragmatic function. After BPBAC, global diaphragm function reduces due to ipsilateral hemidiaphragm reduction, but less than expected due to the increase in the contralateral hemidiaphragm function. As a part of the diaphragm function, the contralateral hemidiaphragm function plays a relevant role in the appearance of PPC.

详细描述

INTRODUCTION Shoulder surgery is known to be a particularly painful stimulus. Perioperative analgesia using brachial plexus block by injection above the clavicle (BPBAC) for shoulder surgery is the standard of care 1,2.

Up to date, ipsilateral diaphragmatic paresis after BPBAC is still very frequent, but few patients develop postoperative pulmonary complications (PPC), and most of them are mild8. There is much concern in avoiding ipsilateral hemidiaphragmatic paralysis to reduce PPC. Little attention has been paid to the contralateral diaphragm and the global diaphragmatic function formed by both hemidiaphragms (the ipsilateral and the contralateral to the BPBAC).

A meticulous study of perioperative diaphragm evolution is needed to answer why some patients after BPBAC develop PPC and others do not.

OUTCOMES The primary objective was to examine the evolution of perioperative hemidiaphragm function with ultrasound (ipsilateral and contralateral) when using BPBAC following shoulder surgery.

the hypothesis is that despite frequent acute ipsilateral hemidiaphragm paralysis after BPBAC, the contralateral hemidiaphragm function increases and preserves global diaphragmatic function in most patients.

研究设计

研究类型
Observational
观察模型
Cohort
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 scheduled for any type of surgery that requires a supraclavicular or interscalene block.

排除标准

  • Age <18 years
  • No locoregional blockade over the clavicular for any reason, allergy to local anesthetics, coagulopathy, clinical reason.
  • Rejection to enter the observational study

结局指标

主要结局

Contralateral Diaphragm function change

时间窗: day of surgery (1 hour before surgery starts and 1 hour after surgery ends)

Thickening fraction (%) change of contralateral hemidiaphragm Before-After Brachial plexus Block

次要结局

  • Incidence of contralateral hemidiaphragm increase after BPBAC.(POSTOPERATIVE 30 min after surgery at PACU (post anesthesia care unit))
  • Ipsilateral Diaphragm function change(day of surgery (1hour before surgery starts and 1hour after surgery ends))
  • Incidence of Postoperative Pulmonary Complications(postoperative 30 min after surgery at PACU(post anesthesia care unit))

研究者

发起方
Hospital General Universitario de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucas Rovira

Principal Investigator

Hospital General Universitario de Valencia

研究点 (1)

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