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Ultrasonographic Identification of the Proximal Humerus Landmarks

2020年9月16日 更新者:SergioB17、The Cleveland Clinic

Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus

Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.

研究概览

详细说明

There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).

研究类型

观察性的

注册 (实际的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study.

Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI > 40 kg/m2.

描述

Inclusion Criteria:

  • Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
  • BMI >= 18.5 kg/m^2

Exclusion Criteria:

  • Limited mobility/ range of motion of arms
  • Prior surgical intervention on shoulder or humerus
  • History of arm dislocation with internal rotation
  • History of arm fracture
  • BMI in ranges: 25.1 - 29.9, 35.1 - 39.9

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Low BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic
Moderate BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic
High BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI > 40 kg/m2 will receive ultrasound exam.
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of proximal humerus landmarks successfully identified by ultrasound exam
大体时间:Through completion of ultrasonographic exam, an average of 30 minutes.

Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks:

  1. The humeral shaft,
  2. The surgical neck of the humerus,
  3. The lesser tubercle,
  4. The greater tubercle,
  5. The intertubercular sulcus
  6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.
Through completion of ultrasonographic exam, an average of 30 minutes.

次要结果测量

结果测量
措施说明
大体时间
Time used to identify all 6 anatomical landmarks using ultrasound in seconds.
大体时间:Through completion of ultrasonographic exam, an average of 30 minutes.
Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.
Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters.
大体时间:Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters based on ultrasound measurements.
Through completion of ultrasonographic exam, an average of 30 minutes.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月1日

初级完成 (实际的)

2019年10月19日

研究完成 (实际的)

2020年7月7日

研究注册日期

首次提交

2017年3月23日

首先提交符合 QC 标准的

2017年4月17日

首次发布 (实际的)

2017年4月20日

研究记录更新

最后更新发布 (实际的)

2020年9月18日

上次提交的符合 QC 标准的更新

2020年9月16日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 16-1642

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Ultrasonographic exam的临床试验

3
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