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临床试验/NCT07306728
NCT07306728尚未招募不适用

Effect of Femoral Region Ice Bag Application on Patients' Clinical Outcomes

Mansoura University0 个研究点目标入组 60 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Pain Level

研究概览

简要总结

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide, necessitating advancements in diagnostic techniques (Parulkar et al., 2025). According to the British Heart Foundation, over 250 million individuals worldwide are living with CAD, making it the most commonly diagnosed heart condition globally. In 2021, CAD was responsible for approximately 9 million deaths, accounting for about one in every seven deaths globally

详细描述

Complications associated with PCI significantly impact patient outcomes and place substantial demands on healthcare systems. These adverse events contribute to increased morbidity and mortality rates, prolonged hospitalizations, higher healthcare expenditures, and longer 0waiting times for subsequent cardiac procedures. (Guedeney et al., 2024; Ntow, Agyeman, Aryal, & Patel, 2024) . Postoperative pain remains a prevalent concern following PCI, particularly after femoral catheter removal, with approximately 33% of patients reporting discomfort at the access site (Al-Zuhairi & Abed, 2024).

Although this pain typically subsides over time, it can significantly affect patient comfort and recovery in the immediate post-procedural phase. In addition to pain, hematoma formation is among the most frequent vascular complications associated with femoral artery access, with a reported prevalence of up to 15.5% (Zhi et al., 2024). These hematomas, resulting from bleeding at the puncture site, can range from minor bruising to substantial blood collections, potentially leading to pain, swelling, and further clinical complications (Hamdi, Abd El Megeed, Abd Al Ghaffare, & Abdelmowla, 2023). Traditional pressure application remains a commonly employed strategy in clinical settings for managing such hematomas and mitigating their progression (Rodgers et al., 2025).

Cryotherapy, or cold therapy, is a well-established non-pharmacological intervention widely utilized in clinical practice to alleviate pain, reduce swelling, and control inflammation. This method typically involves the localized application of ice packs or bags, which may range from specially designed medical devices to simple waterproof plastic bags (Garcia, Karri, Zacharias, & Abd-Elsayed, 2021). In the context of PCI care, cryotherapy has shown promise in minimizing vascular complications following femoral arterial sheath removal. The application of a cold pack to the femoral region can aid in reducing pain, controlling bleeding, and limiting hematoma formation.

The therapeutic effect is primarily attributed to the vasoconstriction induced by cold exposure, which enhances coagulation, decreases local blood flow, and increases blood viscosity (Al-Bayati & Al-Kassar, 2023). Additionally, it decreases temperature by primarily reducing metabolic activity, which reduces inflammatory response as well as reduces nerve conductivity, thereby slowing pain impulse transmission and decreasing pain perception and tissue damage (Behera & Shetty, 2023).

The significance of this study lies in its potential to enhance post-PCI patient care through a simple, non-pharmacological intervention. Growing evidence supports the clinical effectiveness of ice bag application in managing complications associated with femoral catheter removal. Research by )Al-Zuhairi and Abed 2024), and )Pamuk and Özkaraman 2024), confirmed that localized ice therapy significantly alleviates pain and reduces vascular complications following PCI, emphasizing its role in improving patient comfort and outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Adult patients (aged 18 years and above) who have undergone elective PCI via femoral artery access.
  • 2. Patients who are conscious, oriented, and able to report pain level.
  • Hemodynamically stable post-procedure.

排除标准

  • 1. Patients with active infections
  • Patient with double femoral sheath region.
  • Patients with bleeding scar tissue from burns, wounds or hematoma in the femoral artery area before sheath removal.
  • 4. Patients with known peripheral vascular disease affecting the femoral artery.
  • 5. Allergy or contraindication to cold application.
  • Active bleeding at the access site.
  • Patients receiving anti-coagulation therapy beyond the standard post-PCI protocol.

结局指标

主要结局

Pain Level

时间窗: 3 months

Assessed using a standardized pain scale

次要结局

  • Hematoma Formation(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hussein Abdeltawab Abdelmoneim Hussein Glalah

Nursing specialist

Mansoura University

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