NCT04438772

Brief Summary

Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 15, 2020

Last Update Submit

June 18, 2020

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • Cormack score

    from 0 to 4

    During laryngoscopy

Secondary Outcomes (1)

  • Time to intubation

    During laryngoscopy

Study Arms (2)

LPEC

EXPERIMENTAL
Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia

Sham procedure

SHAM COMPARATOR
Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia

Interventions

Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesiaOTHER

Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition

LPECSham procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubation

You may not qualify if:

  • ENT neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javillier

Liège, 4000, Belgium

RECRUITING

Study Officials

  • Benjamin Javillier, MD

    University of Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Javillier, MD

CONTACT

003243667180benjamin.javillier@chuliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 19, 2020

Study Start

June 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

BE(1)