Effect of LPEC Compared With a Sham Procedure in the General Anesthesia

June 18, 2020 updated by: Benjamin Javillier, University of Liege
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intubation

Exclusion Criteria:

  • ENT neoplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham procedure
Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition
Experimental: LPEC
Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack score
Time Frame: During laryngoscopy
from 0 to 4
During laryngoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to intubation
Time Frame: During laryngoscopy
During laryngoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Principal Investigator: Benjamin Javillier, MD, University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPEConditions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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