NCT01415661

Brief Summary

This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

August 4, 2011

Last Update Submit

April 7, 2012

Conditions

Aspiration

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Cricoid Pressure for Prevention of Aspiration

    24 hours

Study Arms (2)

obese patient

EXPERIMENTAL
Other: cricoid pressure

non obese patient

EXPERIMENTAL
Other: cricoid pressure

Interventions

cricoid pressureOTHER

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.

Also known as: Glidescope
non obese patientobese patient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese patients ( BMI 40-70 kg/m2)
  • No Contre indication to cricoid pressure
  • No-obese patients (BMI \< 40)

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

Location

Study Officials

  • AHED ZEIDAN, MD

    Procare Riaya Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 12, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

SA(1)