Anaphylactic ShockDEEPNCT02886468
DEpth of EPinephrine Delivery With Auto-injectors Devices
A study testing skin ultrasound in people with Anaphylactic Shock, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaphylactic Shock
- What is being tested?
- skin ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2016to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- having a skin lesion on the lateral aspect of the thigh,
- with a known or suspected allergy to the contact gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens
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
- Conditions
- Anaphylactic Shock
- Being tested
- skin ultrasound
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin ultrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| ultrasound images | Experimental | ultrasound images of the anterolateral aspect of the mid-right thigh Receives: Other: skin ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start26 Aug 2016
- Primary completion4 May 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaphylactic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886468
- Sponsor's protocol ID
- 2016-03-CHRMT
- Acronym
- DEEP
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38740133
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Muscle - Skin Distance at the Injection Site in Patients With an Indication for the Use of Epinephrine Auto- Injector Pens
- ClinicalTrials.gov ID
- NCT02886468
- Acronym / sponsor ID
- DEEP / 2016-03-CHRMT
- Conditions
- Anaphylactic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound images | Experimental | Other: skin ultrasoundultrasound images of the anterolateral aspect of the mid-right thigh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (2 listed)
- having a skin lesion on the lateral aspect of the thigh,
- with a known or suspected allergy to the contact gel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin ultrasound | Other | ultrasound images |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Results publication: PubMed 38740133Lefevre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin ultrasound in people with Anaphylactic Shock, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.