DEpth of EPinephrine Delivery With Auto-injectors Devices

Not Applicable

Completed

• Conditions: Anaphylactic Shock
• Interventions: Other: skin ultrasound

• Registration Number: NCT02886468
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight\> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-26
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-01
• Primary Completion: 2021-05-04
• Status Verified: 2021-08
• Study Completion: 2021-08-16
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• a weight of over 30 kg at Baseline
• with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations,

Exclusion Criteria

• having a skin lesion on the lateral aspect of the thigh,
• with a known or suspected allergy to the contact gel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasound images	skin ultrasound	ultrasound images of the anterolateral aspect of the mid-right thigh

Primary Outcome Measures

Name	Time	Method
Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.	Day 1

Trial Locations

Locations (1)

Chr Metz Thionville; 🇫🇷 Metz, France