AzTrials
AzTrials

AspirationCPNCT01746927

Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen

An observational study of Aspiration, run by Procare Riaya Hospital at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Aspiration
What is being tested?
Glidescope Cricoid pressure
How many people
80 participants
Where
1 siteSaudi Arabia
Study dates
Feb 2012to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: normal healthy non obese patients

Who may be able to join

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

Who cannot join

  • ASA 3 and 4
  • Contre indication to cricoid pressure

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site, 1 recruiting
  • Procare Riaya Hospital

    Khobar, Estern, 31952

    Kamal Abdulkhalek, M.D., 00966505814754 ext. 1140, doczeidan@hotmail.com

    AHED ZEIDAN, MD

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Does the Position of the Esophageal Entrance Determine the Cricoid Force Necessary to Occlude the Esophageal Lumen?

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).

Read the detailed description

80 adult patients (40 women, 40 men) scheduled to undergo elective surgical procedures requiring general anesthesia and necessitating endotracheal intubation, were included in this study. Patients eligible for participation were aged 18-60 yrs., ASA physical status I or II and BMI < 30 kg/m2. Before anesthesia induction, CP was verified as follow: the cricoid cartilage was first identified and then held between the thumb and middle finger and the pressure was applied by the index finger with a force that could be tolerated by the patient. After loss of consciousness, four predetermined forces: 0 , 10 , 20 and 30 N were chosen in a randomized method. Therefore, after applying the predetermined force, a GT 20 F insertion trial was performed and two outcomes were considered: 1) Failure of GT insertion: effective CP. The next trials were not attempted. 2) Success of GT insertion: ineffective CP. The patient received a second attempt with increasing force to the next scale of force. If the attempt was effective (failure of GT insertion) , the relevant force is considered as the effective CP force. Same trial was repeated using 0, 10, 20 and 30 N respectively in in a randomized fashion for each patient. The cricoid force was standardized by reproducing 10, 20 and 30 N on a weighing scale prior to each application.

Four anesthesia providers (operators) participated in the study: The first operator performed CP in all patients with his back towards the video monitor; the second operator performed laryngoscopy using GVL and GT insertion trials and he was not aware about the nature of study ; the third operator assessed the effectiveness of the applied CP and determined the position of the esophageal entrance in relation to the glottis. The fourth operator, who was standing behind the second operator, signaled to the second operator to start attempt for each trial with the predetermined CP forces and to the first operator who applying CP to stop or continue accordingly.

In order to "blind" the second operator, a screen separated the laryngoscopist and the first operator applying CP, while the hand position for the CP was maintained, even when CP was not applied. Data collected before staring surgery.

Conditions
Aspiration
Being tested
Glidescope Cricoid pressure
Keywords
cricoid pressure, glidescope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glidescope 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. using in radimized method : 0 N,10 N, 20N AND 30 N

Study groups in NCT01746927
Study groupRoleWhat they receive
cricoid pressureNot described
Receives: Other: Glidescope Cricoid pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Cricoid Pressure for Prevention of Aspiration

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746927
Sponsor's protocol ID
PRH05
Acronym
CP
Status last verified
Dec 2013
First submitted
7 Dec 2012
Last updated
3 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aspiration, run by Procare Riaya Hospital at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Cricoid Pressure for Prevention of Aspiration (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in