Ultrasound-Guided Assessment of Ventrogluteal Intramuscular Injection in Adults With High BMI

NCT07827300 | Completed

• 1 other identifier: 325S418
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventrogluteal Injection; Nursing Care

Keywords

Body Mass Index; Ventrogluteal Site; Intramuscular Injection; G Method; Needle Length; Ultrasonography

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (1)

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.

Procedure: Ventrogluteal Intramuscular Injection Using a 40 mm Needle

Interventions

Ventrogluteal Intramuscular Injection Using a 40 mm Needle PROCEDURE

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 in real time using ultrasonography to evaluate its intramuscular position, including its distance from the superficial muscle fascia and the ilium. The position of the needle tip relative to the sciatic nerve was also assessed.

Ventrogluteal Intramuscular Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Needles

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 18, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)