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

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 Overview

• Status: Completed
• Conditions: MRI
• Intervention / Treatment: Procedure: mobilization of the larynx

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Javillier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults

Description

Inclusion Criteria:

• Adults Volunteers

Exclusion Criteria:

• Pregnancy
• Claustrophob
• Thyroid goiter

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mobilization of the larynx; we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC	Procedure: mobilization of the larynx; we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ANESAM2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No