MRI STUDY OF THE LPEC
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
1 other identifier
observational
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Shorter than P25 for all trials
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
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
October 12, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedOctober 17, 2019
October 1, 2019
2 months
October 12, 2019
October 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
End of the MRI
Study Arms (1)
mobilization of the larynx
we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC
Interventions
we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC
Eligibility Criteria
Adults
You may qualify if:
- Adults Volunteers
You may not qualify if:
- Pregnancy
- Claustrophob
- Thyroid goiter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Javillier
Liège, 4000, Belgium
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 12, 2019
First Posted
October 15, 2019
Study Start
February 1, 2019
Primary Completion
April 1, 2019
Study Completion
September 30, 2019
Last Updated
October 17, 2019
Record last verified: 2019-10