The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children

June 14, 2023 updated by: Mineto Kamata
A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.

Description

Inclusion Criteria:

  • Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.

Exclusion Criteria:

  • Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cuffed ETT
Airway secured using a cuffed endotracheal tube.
Device: Cuffed ETT
Cuffed endotracheal tube.
LMA 2
Airway secured using a size 2 laryngeal mask airway.
Device: Cuffed LMA
Cuffed laryngeal mask airway.
LMA 2.5
Airway secured using a size 2.5 laryngeal mask airway.
Device: Cuffed LMA
Cuffed laryngeal mask airway.
LMA 3
Airway secured using a size 3 laryngeal mask airway.
Device: Cuffed LMA
Cuffed laryngeal mask airway.
LMA 4
Airway secured using a size 4 laryngeal mask airway.
Device: Cuffed LMA
Cuffed laryngeal mask airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracuff Pressures During Probe Insertion
Time Frame: At time of EGD probe insertion
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
At time of EGD probe insertion
Intracuff Pressure With Probe in Place
Time Frame: At time of EGD while probe is in place
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.
At time of EGD while probe is in place
Intracuff Pressure After Probe Removal
Time Frame: Immediately after probe removal
Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.
Immediately after probe removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mineto Kamata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimated)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB15-01074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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