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

NCT ID: NCT03432403

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Intracuff Pressure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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New LMA or Old LMA

newly designed LMA or older designed LMA

Ambu LMA

Intervention Type DEVICE

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

Gastro LMA

Intervention Type DEVICE

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

Interventions

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Ambu LMA

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

Intervention Type DEVICE

Gastro LMA

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

Intervention Type DEVICE

Other Intervention Names

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old LMA new LMA

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jason Bryant

OTHER

Sponsor Role lead

Responsible Party

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Jason Bryant

Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-00680

Identifier Type: -

Identifier Source: org_study_id

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