MRINCT04127630
MRI STUDY OF THE LPEC
An observational study of MRI, run by University of Liege at 1 site in Belgium.
Trial summary
Cricoid pressure is still considered as a standard of care in order to prevent the gastric regurgitation in full stomach surgery1. However, this attitude has been challenged in several case reports as oesophageal rupture, difficult intubation, and even failing to occlude the oesophagus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MRI
- What is being tested?
- mobilization of the larynx
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2019to 30 Sep 2019
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Adults
Who may be able to join
- Adults Volunteers
Who cannot join
- Pregnancy
- Claustrophob
- Thyroid goiter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation in MRI of the Impact of the Sellick Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on the Displacement of the Laryngeal Mass and the Visualization of the Vocal Cords
Cricoid pressure is still considered as a standard of care in order to prevent the gastric regurgitation in full stomach surgery1.
However, this attitude has been challenged in several case reports as oesophageal rupture, difficult intubation, and even failing to occlude the oesophagus. Moreover, in a large prospective randomized study , this maneuver has failed to show a definite benefit2.
Read more
The lateral deviation to the left of the oeso deviate to the left side3,4 has led to the description of a new maneuver to compress directly the oesophagus at the low left paratracheal level. This maneuver has been shown to prevent gastric air insuflation during the ventilation.
In the present study, the investigators aim to asses with an magnetic resonance imaging the compressibility of the oesophagus.
- Conditions
- MRI
- Being tested
- mobilization of the larynx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization of the larynxProcedure or surgery
we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC
| Study group | Role | What they receive |
|---|---|---|
| mobilization of the larynx | we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC Receives: Procedure: mobilization of the larynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oesophagus compressibility
Analysis of the position of the Oesophagus is obtained in the three groups in a upper position ( C5-6) and lower position (C8-T1). The upper position is the first view were the oesophagus is clearly identified: In fact, the pressure exerted during the cricoid maneuver is in fact applied in the area of the hypopharynx above the osophagus. The oesophagus is quoted relatively to the vertebral body as Medial (80% facing the vertebral body) Medio-lateral , lateral (20% facing the vertebral body).
Measured: End of the MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Apr 2019
- Study completion30 Sep 2019
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 MRIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127630
- Sponsor's protocol ID
- ANESAM2019
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Javillier B, Gautier N, Meunier A, Balocco AL, Meunier P, Gautier P. Anatomical Superiority of Paratracheal Over Cricoid Pressure: Magnetic Resonance Imaging Study. Anesth Analg. 2026 Jun 1;142(6):1232-1235. doi: 10.1213/ANE.0000000000007847. Epub 2025 Nov 25. No abstract available.
PubMed 41319688
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in MRI of the Impact of the Sellick Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on the Displacement of the Laryngeal Mass and the Visualization of the Vocal Cords
- ClinicalTrials.gov ID
- NCT04127630
- Acronym / sponsor ID
- ANESAM2019
- Conditions
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 15 Oct 2019 (actual)
- 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.
Cricoid pressure is still considered as a standard of care in order to prevent the gastric regurgitation in full stomach surgery1.
However, this attitude has been challenged in several case reports as oesophageal rupture, difficult intubation, and even failing to occlude the oesophagus. Moreover, in a large prospective randomized study , this maneuver has failed to show a definite benefit2.
The lateral deviation to the left of the oeso deviate to the left side3,4 has led to the description of a new maneuver to compress directly the oesophagus at the low left paratracheal level. This maneuver has been shown to prevent gastric air insuflation during the ventilation.
In the present study, the investigators aim to asses with an magnetic resonance imaging the compressibility of the oesophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mobilization of the larynx | – | Procedure: mobilization of the larynxwe aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (1 listed)
- Adults Volunteers
Key exclusion criteria (3 listed)
- Pregnancy
- Claustrophob
- Thyroid goiter
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 |
|---|---|---|
| mobilization of the larynxwe aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC | Procedure or surgery | mobilization of the larynx |
Primary outcome
Oesophagus compressibility
Time frame: End of the MRI
Analysis of the position of the Oesophagus is obtained in the three groups in a upper position ( C5-6) and lower position (C8-T1). The upper position is the first view were the oesophagus is clearly identified: In fact, the pressure exerted during the cricoid maneuver is in fact applied in the area of the hypopharynx above the osophagus. The oesophagus is quoted relatively to the vertebral body as Medial (80% facing the vertebral body) Medio-lateral , lateral (20% facing the vertebral body).
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 17 Oct 2019.
- Derived from this study: PubMed 41319688Javillier B, Gautier N, Meunier A, Balocco AL, Meunier P, Gautier P. Anatomical Superiority of Paratracheal Over Cricoid Pressure: Magnetic Resonance Imaging Study. Anesth Analg. 2026 Jun 1;142(6):1232-1235. doi: 10.1213/ANE.0000000000007847. Epub 2025 Nov 25. No abstract available.
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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?
An observational study of MRI, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 3 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 17 Oct 2019. 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 Belgium. 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?
Oesophagus compressibility (time frame: End of the MRI). 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 NCT04127630, 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 17 Oct 2019.