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DEpth of EPinephrine Delivery With Auto-injectors Devices (DEEP)

Primary Purpose

Anaphylactic Shock

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
skin ultrasound
Sponsored by
Centre Hospitalier Régional Metz-Thionville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anaphylactic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chr Metz Thionville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasound images

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2016
Last Updated
August 25, 2021
Sponsor
Centre Hospitalier Régional Metz-Thionville
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1. Study Identification

Unique Protocol Identification Number
NCT02886468
Brief Title
DEpth of EPinephrine Delivery With Auto-injectors Devices
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 26, 2016 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylactic Shock

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound images
Arm Type
Experimental
Arm Description
ultrasound images of the anterolateral aspect of the mid-right thigh
Intervention Type
Other
Intervention Name(s)
skin ultrasound
Primary Outcome Measure Information:
Title
Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chr Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France

12. IPD Sharing Statement

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DEpth of EPinephrine Delivery With Auto-injectors Devices

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