DEpth of EPinephrine Delivery With Auto-injectors Devices
DEEP
Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens
1 other identifier
interventional
107
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2016
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2021
CompletedAugust 26, 2021
August 1, 2021
4.7 years
August 29, 2016
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ultrasound images
EXPERIMENTALultrasound images of the anterolateral aspect of the mid-right thigh
Interventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- having a skin lesion on the lateral aspect of the thigh,
- with a known or suspected allergy to the contact gel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chr Metz Thionville
Metz, 57085, France
Related Publications (1)
Lefevre S, Goetz C, Hennequin L, Zevering Y, Dinot V. Frequencies and predictors of subcutaneous and intraosseous injection with 4 epinephrine autoinjector devices. Ann Allergy Asthma Immunol. 2024 Aug;133(2):194-202.e5. doi: 10.1016/j.anai.2024.05.002. Epub 2024 May 11.
PMID: 38740133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2016
First Posted
September 1, 2016
Study Start
August 26, 2016
Primary Completion
May 4, 2021
Study Completion
August 16, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08