NCT03432403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

January 23, 2018

Last Update Submit

September 8, 2020

Conditions

Intracuff Pressure

Outcome Measures

Primary Outcomes (1)

  • Excessive intracuff pressure

    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.

    as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes

Study Arms (1)

New LMA or Old LMA

newly designed LMA or older designed LMA

Device: Ambu LMADevice: Gastro LMA

Interventions

Ambu LMADEVICE

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

Also known as: old LMA
New LMA or Old LMA
Gastro LMADEVICE

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

Also known as: new LMA
New LMA or Old LMA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who weigh more than 30 kg who are undergoing an EGD and who are getting an LMA at Nationwide Children's Hospital.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 14, 2018

Study Start

November 15, 2017

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(1)