Intracuff PressureNCT03432403
The Effect of EGD Scope Insertion on the Intracuff Pressure of a New, Modified LMA in Children
An observational study of Intracuff Pressure, run by Jason Bryant at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracuff Pressure
- What is being tested?
- Ambu LMA and Gastro LMA
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who weigh more than 30 kg
- Patients undergoing an EGD
- Patients getting an LMA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway 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.
- Conditions
- Intracuff Pressure
- Being tested
- Ambu LMA, Gastro LMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu LMADevice
Also called old LMA
Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
Gastro LMADevice
Also called new LMA
Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
| Study group | Role | What they receive |
|---|---|---|
| New LMA or Old LMA | newly designed LMA or older designed LMA Receives: Device: Ambu LMA; Device: Gastro LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: as long as the LMA is in place in the OR with usually a max amount of time of 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start15 Nov 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracuff PressureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Bryant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Bryant, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432403
- Sponsor's protocol ID
- IRB17-00680
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esophagogastroduodenoscopy Scope Insertion on the Intracuff Pressure of a New, Modified Laryngeal Mask Airway in Children
- ClinicalTrials.gov ID
- NCT03432403
- Acronym / sponsor ID
- IRB17-00680
- Conditions
- Intracuff Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jason BryantUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New LMA or Old LMA | – | Device: Ambu LMA, Device: Gastro LMAnewly designed LMA or older designed LMA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients who weigh more than 30 kg
- Patients undergoing an EGD
- Patients getting an LMA
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Ambu LMAAlso: old LMAWill be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured | Device | New LMA or Old LMA |
| Gastro LMAAlso: new LMAWill be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured | Device | New LMA or Old LMA |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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 Intracuff Pressure, run by Jason Bryant 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 3 inclusion and 4 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 9 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 9 Sep 2020.