跳至主要内容
临床试验/NCT04218643
NCT04218643终止不适用

Ultrasound-guided Peripheral Intravenous Catheter Insertion Technique and the Effects on Overall Site Utilization and Failure

The Reading Hospital and Medical Center2 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
227
试验地点
2
主要终点
Post insertion failure rates

研究概览

简要总结

This comparative treatment study aims to challenge a current clinical practice. Specifically, whether the use of ultrasound-guided peripheral intravenous catheter insertion results in lower post insertion failure rates with longer utility time compared to peripheral intravenous catheters (PIVC) inserted in the standard manner during the emergency department (ED), observation and in-patient stay. There are two secondary aims to the study: a) determining if ultrasound-guided peripheral intravenous catheter insertion results in lower post removal complication rates compared to PIVCs inserted in the standard manner; and b) determining if catheter-to-vein ratio can predict post insertion success of PIVCs and what catheter-to-vein ratio is most successful. In this study, catheter-to-vein ratio is defined as the diameter of the lumen of the vein divided by the outside diameter of the catheter.

详细描述

This study is a randomized prospective trial comparing US-guided PIVC insertion with standard PIVC insertion technique. This study will evaluate the predictive strength of catheter-to-vein ratio to PIVC post insertion success.

The study population is all patients presenting to the ED. The sample population will be patients requiring a PIVC for treatment or diagnostic purposes and don't have an existing PIVC (EMS or other). Inclusion and exclusion criteria focusing on most suitable participants and safety will determine the participant population. Participants will be randomized to one of two cohorts; 1) PIVC insertion based on standard technique and 2) US-guided PIVC insertion.

There will be two data collection phases in this study:

Phase one occurs in the emergency department (ED). ED staff will be notified of the study period, however to minimize bias, details of the study will not be given. Patients in this phase include those registered in the ED seeking treatment. To identify potential candidates, the investigator will perform an initial screening by communicating with ED staff. Initial screenings will be recorded without using any identifying data. When a potential participant is identified, the investigator will then coordinate with ED staff, approach the candidate and confirm that they meet inclusion and exclusion criteria. If the patient qualifies for enrollment, the investigator will review the study purpose including risks and benefits of enrolling, and have the patient sign the consent form. Randomization will occur after obtaining consent. Patients will have a PIVC inserted by any qualified Nurse or Medic. The PIVC will be placed according to the Reading Hospital Peripheral Intravenous Therapy for Adults guideline. After the PIVC (Standard or US-guided) is inserted, the investigator will then measure the vein prior to any infusion that could distort vein measurement.

All investigators involved with vein measurement will complete vein measurement training. The vein size will be measured using one of the following US machines: SonoSite Edge II or X-Porte each equipped with a 13-6 MHz, 6 cm linear probe (FUJIFILM SonoSite, Inc. Bothell, WA, USA). The investigator will then record collected data on the phase one data collection form and place the form in a secure container. A member of the research team will then collect the completed data collection forms and enter the data in a secured study database. To limit bias, investigators will not inform the ED staff of the specifics of this study and will only provide enough information for data to be collected safely and accurately. In the event that a PIVC could not be successfully inserted according to the randomized technique, the PIVC will be analyzed in an intention to treat (ITT) format and the participant will receive vascular access as per the treatment team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Identified as requiring a PIVC
  • Acceptable vital signs - not requiring emergent resuscitation

排除标准

  • Patients triaged as MI alert, brain attack alert, and trauma alert
  • Prisoners
  • Institutionalized patients
  • Housing insecurity
  • Unable to provide consent
  • Previously entered into the study

结局指标

主要结局

Post insertion failure rates

时间窗: Duration of catheter dwell time (up to 168 hours)

Failure rate (overall and individual cause/reason)

Overall utility

时间窗: Up to 168 hours (1 week)

The overall dwell time of the catheter

次要结局

  • Post removal complication rates(48 hours after catheter removal)
  • Catheter to vein ratio(Up to 168 hours (1 week))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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