ClinicalTrials.gg
CompletedNCT01415661CPUpdated Apr 10, 2012

Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study

An interventional study of cricoid pressure in Aspiration, sponsored by Procare Riaya Hospital. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Procare Riaya Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

Read the detailed description

Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.

02

Conditions studied

  • Aspiration
03

In context

Lead sponsor

Procare Riaya Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ASA 3 and 4
  • Contre indication to cricoid pressure
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
89 participants (actual)

Study arms

  • Experimental
    obese patient

    Other: cricoid pressure

  • Experimental
    non obese patient

    Other: cricoid pressure

Interventions

  • Othercricoid pressure

    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

06

What researchers measure

Primary outcomes

  1. Efficacy of Cricoid Pressure for Prevention of Aspiration

    Time frame: 24 hours

07

Study locations

1 site
  • procare Riaya Hospital
    Khobar, Estern 31952, Saudi Arabia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2011
First posted
Aug 12, 2011
Start
Jan 2011
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Last update
Apr 10, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01415661
Lead sponsor
Procare Riaya Hospital
Responsible party
Ahed ZEIDAN (MD, Procare Riaya Hospital) — Principal investigator
First posted
Aug 12, 2011
Start date
Jan 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Apr 10, 2012

Study contacts

AHED ZEIDAN, MD
study chair · Procare Riaya Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion