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The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children

The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03432403
Enrollment
200
Registered
2018-02-14
Start date
2017-11-15
Completion date
2019-12-20
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracuff Pressure

Brief summary

The purpose of this current study is to compare changes of the intracuff pressure in the newly designed LMA with the older design LMA after insertion of an esophagogastroduodenoscopy (EGD) probe in pediatric patients and adolescents.

Interventions

DEVICEAmbu LMA

Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured

DEVICEGastro LMA

Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured

Sponsors

Jason Bryant
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who weigh more than 30 kg * Patients undergoing an EGD * Patients getting an LMA

Exclusion criteria

* Patients who weigh less than 30 kg * Use of an EGD probe with an OD greater than 14 mm * Decision not to use an LMA for the procedure * Tracheomalacia, bronchomalacia, or any other airway issues

Design outcomes

Primary

MeasureTime frameDescription
Excessive intracuff pressureas long as the LMA is in place in the OR with usually a max amount of time of 45 minutesOur primary goal is to compare the incidence of excessive intracuff pressure after EGD probe insertion between the newly designed LMA and the older version LMA. For this primary outcome, we will define excessive intracuff pressure as ≥40 cmH2O.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026