The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2015
Shorter than P25 for all trials
1 active site
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
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
December 30, 2019
CompletedJune 15, 2023
June 1, 2023
10 months
December 30, 2015
April 19, 2017
June 14, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Intracuff Pressures During 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
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
Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.
Immediately after probe removal
Study Arms (5)
Cuffed ETT
Airway secured using a cuffed endotracheal tube.
LMA 2
Airway secured using a size 2 laryngeal mask airway.
LMA 2.5
Airway secured using a size 2.5 laryngeal mask airway.
LMA 3
Airway secured using a size 3 laryngeal mask airway.
LMA 4
Airway secured using a size 4 laryngeal mask airway.
Interventions
Eligibility Criteria
Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.
You may qualify if:
- Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.
You may not qualify if:
- Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mineto Kamatalead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Results Point of Contact
- Title
- Mineto Kamada
- Organization
- Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Anesthesia Clinical Fellow
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 1, 2016
Study Start
December 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
June 15, 2023
Results First Posted
December 30, 2019
Record last verified: 2023-06