CompletedNCT02645019Updated Jun 15, 2023Results posted

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

An observational study in Esophagogastroduodensocopy (EGD) Procedure, sponsored by Mineto Kamata. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Mineto Kamata · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 100
Ages: Up to 18 Years
Sex: All

Study 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.

Conditions studied

Esophagogastroduodensocopy (EGD) Procedure

In context

Lead sponsor

This is the only study on the registry with Mineto Kamata as lead sponsor.

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

Who can participate

Ages eligible: Up to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 100 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

DeviceCuffed ETT
Cuffed endotracheal tube.
DeviceCuffed LMA
Cuffed laryngeal mask airway.

What researchers measure

Primary outcomes

Intracuff Pressures During Probe Insertion
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after probe removal

Results

Posted Dec 30, 2019

Participant flow

Participant flow — Overall Study
Milestone	Cuffed ETT	LMA 2	LMA 2.5	LMA 3	LMA 4
Started	13	15	15	33	24
Completed	13	15	15	33	24
Not completed	0	0	0	0	0

Outcome measures

PrimaryIntracuff Pressures During Probe Insertion

Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.

Time frame:: At time of EGD probe insertion
Reported as:: Mean · cmH2O

Intracuff Pressures During Probe Insertion
cmH2O	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT
Intracuff Pressures During Probe Insertion	22 ± 14	34 ± 9	41 ± 15	37 ± 12	24 ± 25

PrimaryIntracuff Pressure With Probe in Place

Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.

Time frame:: At time of EGD while probe is in place
Reported as:: Mean · cmH2O

Intracuff Pressure With Probe in Place
cmH2O	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT
Intracuff Pressure With Probe in Place	22 ± 14	35 ± 9	39 ± 13	36 ± 11	24 ± 25

PrimaryIntracuff Pressure After Probe Removal

Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.

Time frame:: Immediately after probe removal
Reported as:: Mean · cmH2O

Intracuff Pressure After Probe Removal
cmH2O	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT
Intracuff Pressure After Probe Removal	15 ± 11	26 ± 10	31 ± 11	29 ± 10	21 ± 25

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
LMA 2	0/15 (0%)	0/15 (0%)	0/15 (0%)
LMA 2.5	0/15 (0%)	0/15 (0%)	0/15 (0%)
LMA 3	0/33 (0%)	0/33 (0%)	0/33 (0%)
LMA 4	0/24 (0%)	0/24 (0%)	0/24 (0%)
Cuffed ETT	0/13 (0%)	0/13 (0%)	0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT	Total
<=18 years	15	15	33	24	13	100
Between 18 and 65 years	0	0	0	0	0	0
>=65 years	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT	Total
Female	9	7	19	10	7	52
Male	6	8	14	14	6	48

Intracuff pressure immediately following intubation
Intracuff pressure immediately following intubation(cmH2O)	LMA 2	LMA 2.5	LMA 3	LMA 4	Cuffed ETT	Total
Mean	15 ± 13	25 ± 10	34 ± 10	32 ± 10	19 ± 26	27 ± 15

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02645019
Lead sponsor: Mineto Kamata
Responsible party: Mineto Kamata (Anesthesia Clinical Fellow, Nationwide Children's Hospital) — Sponsor-investigator
First posted: Jan 1, 2016
Start date: Dec 2015
Primary completion: Oct 2016
Completion: Oct 2016
Results posted: Dec 30, 2019
Last update: Jun 15, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. 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.

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