跳至主要内容
临床试验/NCT04570722
NCT04570722已完成不适用

Implementing Ipsilateral Peripheral Intravenous Access Procedures for Routine Scanning in Patients With a History of Surgical Axillary Procedures (The iPIVAP Study)

Duke University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年9月20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
3
试验地点
2
主要终点
Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.

研究概览

简要总结

This pilot study will examine facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection in a single radiology center.

详细描述

This prospective single arm study will be conducted within DUH Department of Radiology CT Imaging. The study team will enroll 50 patients with a history of axillary SLNP presenting for routine radiographic scan to undergo ipsilateral IV insertion. Patients will complete baseline bilateral arm volumetric measurements and self-reported symptom assessments. Patients will be followed every 3 months for 1-year duration for development of lymphedema. Patient acceptance or reluctance to ipsilateral IV access will be categorized at time of screening. Staff uptake on practice change will be assessed through medical record documentation for number, location, and factors affecting IV attempts and their perceptions of practice change and acceptance at the end of one year.

All participants will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Per DUH policy, participants will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt. At the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt.

Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur within 2 weeks; findings will be discussed with their physician. Participants will undergo bilateral volumetric measurements, symptom assessments, and perceptions of the ipsilateral IV access protocol at the end of one year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • History of bilateral or unilateral axillary SLNP (sentinel biopsy, lymphadenectomy or dissection) and a previous or current failed contralateral IV attempt or at the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt
  • Scheduled to undergo routine imaging scan with contrast
  • 18 years of age and older
  • Read, reviewed and signed study-specific consent

排除标准

  • Active swelling, rash, or injury in bilateral upper extremities
  • Subjects with diabetes, sickle cell disease, and/or peripheral vascular insufficiency as vascular inflammatory processes pose a lymphedema risk

结局指标

主要结局

Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.

时间窗: Through study completion, an average of 2 years.

Perceptions of barriers and facilitators by staff will be collected at study end using a qualitative format. Modeled after Melnyk, Fineout-Overholt, and Mays (2008) EBP surveys, open-ended questions will be asked during a focus group to ascertain their perceptions of the impact of the ipsilateral IV access protocol. Staff will be asked what worked well, what barriers did they experience, and what do they recommend for protocol adoption. Constant comparative analysis will be used to categorize themes from their responses

次要结局

  • Self reported lymphedema changes :patient reported outcomes (PRO)(Baseline, every 3 months after intervention for 12 months)
  • Lymphedema symptoms; patient reported outcomes (PRO)(Baseline, every 3 months after intervention for 12 months)
  • Study participation acceptance(Baseline)
  • Volumetric measurements(Baseline and at 12 months post ipsilateral IV insertion)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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