NCT01746927

Brief Summary

This investigation was designed to assess if the the position of esophageal entrance would detrmine the cricoid force necessary to occlude the esophageal lumen? in anesthetized, paralyzed non obese patients using the Glidescope ® video laryngoscope (GVL).

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

December 7, 2012

Last Update Submit

December 2, 2013

Conditions

Keywords

cricoid pressure, glidescope

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Cricoid Pressure for Prevention of Aspiration

    24 hours

Study Arms (1)

cricoid pressure

Other: Glidescope Cricoid pressure

Interventions

The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP. using in radimized method : 0 N,10 N, 20N AND 30 N

cricoid pressure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

normal healthy non obese patients

You may qualify if:

  • No-obese patients (BMI \< 30)
  • ASA 1\&2
  • G.A needs intubation

You may not qualify if:

  • ASA 3 and 4
  • Contre indication to cricoid pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Procare Riaya Hospital

Khobar, Estern, 31952, Saudi Arabia

RECRUITING

Study Officials

  • Ahed Zeidan, MD

    Procare Riaya Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT ANESTHESIELOGIST

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations