DEpth of EPinephrine Delivery With Auto-injectors Devices

NCT ID: NCT02886468

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-26

Study Completion Date

2021-08-16

Brief Summary

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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

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Conditions

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Anaphylactic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ultrasound images

ultrasound images of the anterolateral aspect of the mid-right thigh

Group Type EXPERIMENTAL

skin ultrasound

Intervention Type OTHER

Interventions

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skin ultrasound

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chr Metz Thionville

Metz, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38740133 (View on PubMed)

Other Identifiers

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2016-03-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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