DEpth of EPinephrine Delivery With Auto-injectors Devices

Anaphylactic Shock Clinical Trial

— DEEP  

Official title:

Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886468
• Other study ID #: 2016-03-CHRMT
• Status: Completed
• Phase: N/A
• Start date: August 26, 2016
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 16, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaphylactic Shock
• Anaphylaxis

Intervention

Other:
• skin ultrasound

Locations

Country	Name	City	State
France	Chr Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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