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

Completed

• Conditions: Esophagogastroduodensocopy (EGD) Procedure
• Interventions: Device: Cuffed ETT; Device: Cuffed LMA

• Registration Number: NCT02645019
• Lead Sponsor: Mineto Kamata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2019-12-12
• Results First Posted: 2019-12-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cuffed ETT	Cuffed ETT	Airway secured using a cuffed endotracheal tube.
LMA 4	Cuffed LMA	Airway secured using a size 4 laryngeal mask airway.
LMA 2	Cuffed LMA	Airway secured using a size 2 laryngeal mask airway.
LMA 2.5	Cuffed LMA	Airway secured using a size 2.5 laryngeal mask airway.
LMA 3	Cuffed LMA	Airway secured using a size 3 laryngeal mask airway.

Primary Outcome Measures

Name	Time	Method
Intracuff Pressures During Probe Insertion	At time of EGD probe insertion	Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
Intracuff Pressure With Probe in Place	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.
Intracuff Pressure After Probe Removal	Immediately after probe removal	Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States