Esophagogastroduodensocopy (EGD) ProcedureNCT02645019
The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children
An observational study of Esophagogastroduodensocopy (EGD) Procedure, run by Mineto Kamata at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Esophagogastroduodensocopy (EGD) Procedure
- What is being tested?
- Cuffed ETT and Cuffed LMA
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.
Who may be able to join
- Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.
Who cannot join
- Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
- Being tested
- Cuffed ETT, Cuffed LMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed ETTDevice
Cuffed endotracheal tube.
Cuffed LMADevice
Cuffed laryngeal mask airway.
| Study group | Role | What they receive |
|---|---|---|
| Cuffed ETT | Airway secured using a cuffed endotracheal tube. Receives: Device: Cuffed ETT | |
| LMA 2 | Airway secured using a size 2 laryngeal mask airway. Receives: Device: Cuffed LMA | |
| LMA 2.5 | Airway secured using a size 2.5 laryngeal mask airway. Receives: Device: Cuffed LMA | |
| LMA 3 | Airway secured using a size 3 laryngeal mask airway. Receives: Device: Cuffed LMA | |
| LMA 4 | Airway secured using a size 4 laryngeal mask airway. Receives: Device: Cuffed LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff Pressures During Probe Insertion
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
Measured: 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.
Measured: 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.
Measured: Immediately after probe removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophagogastroduodensocopy (EGD) ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mineto Kamata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mineto Kamata, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645019
- Sponsor's protocol ID
- IRB15-01074
- Status last verified
- Jun 2023
- First submitted
- 30 Dec 2015
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children
- ClinicalTrials.gov ID
- NCT02645019
- Acronym / sponsor ID
- IRB15-01074
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mineto KamataUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cuffed ETT | – | Device: Cuffed ETTAirway secured using a cuffed endotracheal tube. |
| LMA 2 | – | Device: Cuffed LMAAirway secured using a size 2 laryngeal mask airway. |
| LMA 2.5 | – | Device: Cuffed LMAAirway secured using a size 2.5 laryngeal mask airway. |
| LMA 3 | – | Device: Cuffed LMAAirway secured using a size 3 laryngeal mask airway. |
| LMA 4 | – | Device: Cuffed LMAAirway secured using a size 4 laryngeal mask airway. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from 0-18 years old having EGD procedure with LMA or cuffed ETT.
Key inclusion criteria (1 listed)
- Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.
Key exclusion criteria (1 listed)
- Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuffed ETTCuffed endotracheal tube. | Device | Cuffed ETT |
| Cuffed LMACuffed laryngeal mask airway. | Device | LMA 2, LMA 2.5, LMA 3, LMA 4 |
Primary outcome
Intracuff Pressures During Probe Insertion
Time frame: At time of EGD probe insertion
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.
Intracuff Pressure With Probe in Place
Time frame: At time of EGD while probe is in place
Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.
Intracuff Pressure After Probe Removal
Time frame: Immediately after probe removal
Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagogastroduodensocopy (EGD) Procedure, run by Mineto Kamata at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracuff Pressures During Probe Insertion (time frame: At time of EGD probe insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.