Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Completed
NCT Number: NCT03432403
The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children
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.
Completed
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ambu LMA
DeviceWill be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
Other names: old LMA
Gastro LMA
DeviceWill be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
Other names: new LMA
Primary outcomes
-
Excessive intracuff pressure
Time frame: as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes
Our 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.
Sponsors and collaborators
Lead sponsor
Jason Bryant
Other
Registry information
Official study title
The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children
Important dates
- Study start
- 2017
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Feb 14, 2018
- Registry last updated
- Sep 9, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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