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临床试验/NCT07827300
NCT07827300已完成不适用

Ventrogluteal Intramuscular Injection in Individuals With High Body Mass Index: Ultrasound-Based Anatomical Measurements and Evaluation of Safe Intramuscular Placement of a 40 mm Needle

Marmara University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle

研究概览

简要总结

This study evaluated the ventrogluteal site for intramuscular injection in adults with a body mass index of 25 kg/m² or higher. Ultrasound was used to measure subcutaneous tissue, muscle, and total tissue thickness at the injection site and the distances from the injection point to anatomical landmarks and the sciatic nerve. During intramuscular injection with a 40 mm needle, real-time ultrasound was used to visualize the needle tip and assess its position within the muscle. The study also evaluated successful intramuscular placement, subcutaneous medication leakage, and injection-related complications. The findings were assessed across three body mass index groups.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and <75 years.
  • Body mass index >24.9 kg/m².
  • A clinical order for intramuscular administration of 1 mL cyanocobalamin at a concentration of 1000 mcg/mL.
  • No muscle atrophy or motor or sensory loss associated with neurological or muscular pathology.
  • Able to walk independently or with assistance and perform activities of daily living.

排除标准

  • Degenerative muscle diseases or motor neuron diseases.
  • Amyotrophic lateral sclerosis or other progressive neuromuscular diseases.
  • Severe muscle atrophy or motor function loss that could affect the reliability of ultrasonographic muscle-thickness measurements.
  • Muscle structure considered unsuitable for reliable ultrasonographic measurement or presence of motor/sensory function loss on clinical evaluation.

研究组 & 干预措施

Ventrogluteal Intramuscular Injection

Experimental

Participants received a ventrogluteal intramuscular injection of 1 mL cyanocobalamin (1000 mcg/mL) using a 40 mm, 21-gauge needle. The injection site was identified using the G method. During the injection, the needle tip was visualized using real-time ultrasonography to assess its intramuscular position and its distances from relevant anatomical structures.

干预措施: Ventrogluteal Intramuscular Injection Using a 40 mm Needle (Procedure)

结局指标

主要结局

Percentage of Participants With Successful Intramuscular Placement of the 40 mm Needle

时间窗: During the injection procedure, immediately after full insertion of the needle and before medication administration

The percentage of participants in whom the 40 mm needle met the predefined intramuscular placement criteria was assessed using real-time ultrasonography. Successful intramuscular placement was defined as the needle tip being at least 10 mm beneath the superficial muscle fascia and at least 10 mm away from the iliac cortex.

次要结局

未报告次要终点

研究者

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

Aynur Kaynar Şimşek

Assistant Professor

Marmara University

研究点 (1)

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