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临床试验/NCT06615063
NCT06615063已完成不适用

Limb Splinting for Intravenous Cannulae in Neonates and Its Effects on Life Span of Intravenous Cannulae; A Randomised Controlled Trial.

Rawalpindi Medical College2 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2022年12月10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
246
试验地点
2
主要终点
lifespan (dwell time) of the intravenous (IV) cannulae.

研究概览

简要总结

The goal of this randomized controlled trial is to assess the effectiveness of limb splinting in increasing the lifespan of intravenous (IV) cannulae in neonates. The study involves neonatal patients requiring peripheral IV cannulation. The main questions it aims to answer are:

Does limb splinting increase the lifespan of IV cannulae compared to non-splinting? What are the effects of splinting on the incidence of complications like extravasation, occlusion, and leakage? Researchers will compare neonates with IV cannulae in splinted limbs to those with IV cannulae in non-splinted limbs to see if splinting extends the cannula's lifespan and reduces complications.

Participants will:

Undergo peripheral IV cannulation with and without limb splinting. Have the lifespan of their IV cannulae monitored and recorded until removal due to various complications or routine changes.

详细描述

This randomized controlled trial aims to investigate the impact of limb splinting on the lifespan of intravenous (IV) cannulae in neonates. The study is motivated by the need to enhance the efficacy and safety of peripheral IV cannulation in neonates, who frequently require intravenous access for the administration of medications and fluids during hospitalization. Peripheral IV cannulation, although common, is associated with a limited dwell time and various complications, including extravasation, occlusion, and leakage, which can lead to multiple cannulations and increased discomfort for neonates.

The study is designed to compare the lifespan of IV cannulae in neonates who have their limbs splinted with those who do not. The primary focus is on whether splinting the limb can effectively increase the dwell time of the IV cannula, thereby reducing the frequency of cannulation and associated complications. The trial involves 246 neonates, randomly assigned to either the splint or non-splint group, with an equal number of participants in each group.

Neonates included in the study will undergo standard peripheral IV cannulation procedures, with all cannulae being inserted by experienced medical staff under controlled conditions. In the splint group, the limb with the IV cannula will be immobilized using a splint, while in the non-splint group, the limb will not be splinted. The time from cannula insertion to removal will be meticulously recorded for each neonate, along with any complications that arise, such as extravasation, accidental dislodgment, infiltration, phlebitis, leakage, or occlusion.

Data will be collected using a self-designed questionnaire, ensuring that the information is only accessible to the primary investigator to maintain data integrity and confidentiality. The study will employ rigorous statistical analysis, including two-sample t-tests to compare the mean dwell times between the splinted and non-splinted groups, and Spearman's rank analysis to explore correlations between various parameters.

The outcomes of this trial are expected to provide valuable insights into the effectiveness of limb splinting as a technique for increasing the lifespan of IV cannulae in neonates. The findings could potentially influence clinical practices by identifying a simple yet effective method to enhance the safety and comfort of neonatal patients requiring IV therapy.

研究设计

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

盲法说明

The description of the study does not explicitly mention any masking (blinding).

In the context provided, the primary investigator collects and analyzes the data using self-designed questionnaires. Typically, in such studies, the intervention (splinting) would be known to the participants and the healthcare providers administering the IV cannulation. Therefore, masking of the participants and providers might not be feasible.

入排标准

年龄范围
1 Hour 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All neonates with intravenous cannulae

排除标准

  • All neonates in neonatal ICU
  • All neonates with central venous line in place
  • All neonates that are on ventilatory support

结局指标

主要结局

lifespan (dwell time) of the intravenous (IV) cannulae.

时间窗: from 0 to 48 hours

The study aims to compare the mean dwell time of IV cannulae between the splinted and non-splinted groups to determine if limb splinting has a significant effect on extending the duration for which the cannula remains functional before removal.

次要结局

  • Incidence of Complications(from 0 to 48 hours)

研究者

发起方
Rawalpindi Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasnain Aslam

Principal Investigator

Rawalpindi Medical College

研究点 (2)

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