Uncuffed Endotracheal IntubationNCT01535300
Ultrasound and Paediatric Endotracheal Tube Size
An observational study of Uncuffed Endotracheal Intubation, run by Heidelberg University at 1 site in Germany.
Trial summary
The aim of the present study was to evaluate the role of ultrasound in paediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different age-related formulas. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Uncuffed Endotracheal Intubation
- What is being tested?
- Ultrasonography of the trachea
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Oct 2010
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children <= 5 years of age scheduled for elective surgery
Who may be able to join
- written informed consent
- children <= 5 years of age
- elective surgery requiring endotracheal intubation
Who cannot join
- missing informed consent
- allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Ultrasound Compared to Age-related Formulas for Uncuffed Endotracheal Intubation in a Paediatric Population
The aim of the present study was to evaluate the role of ultrasound in paediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different age-related formulas.
The investigators hypothesize that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTTD.
- Conditions
- Uncuffed Endotracheal Intubation
- Being tested
- Ultrasonography of the trachea
- Keywords
- Ultrasound, Minimal transverse tracheal diameter, Endotracheal tube size, Paediatric age-based formulas, Sonographic measurement of the trachea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of the tracheaProcedure or surgery
Ultrasonographic measurement of the minimal transverse tracheal diameter
| Study group | Role | What they receive |
|---|---|---|
| Elective pediatric surgery | Not described Receives: Procedure: Ultrasonography of the trachea |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncuffed Endotracheal IntubationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- SonoSite, Inc.
- Responsible party
- Principal investigator, Christoph Schramm, M.D., Heidelberg University
- Investigators
- Konstanze Plaschke, Professor, Study chair, Heidelberg UniversityChristoph Schramm, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535300
- Sponsor's protocol ID
- S234/2010
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound Compared to Age-related Formulas for Uncuffed Endotracheal Intubation in a Paediatric Population
- ClinicalTrials.gov ID
- NCT01535300
- Acronym / sponsor ID
- S234/2010
- Conditions
- Uncuffed Endotracheal Intubation
- Keywords
- Ultrasound, Minimal transverse tracheal diameter, Endotracheal tube size, Paediatric age-based formulas, Sonographic measurement of the trachea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- SonoSite, Inc.
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Feb 2012 (estimated)
- 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 aim of the present study was to evaluate the role of ultrasound in paediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different age-related formulas.
The investigators hypothesize that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTTD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective pediatric surgery | – | Procedure: Ultrasonography of the trachea |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children <= 5 years of age scheduled for elective surgery
Key inclusion criteria (3 listed)
- written informed consent
- children <= 5 years of age
- elective surgery requiring endotracheal intubation
Key exclusion criteria (2 listed)
- missing informed consent
- allergy to ultrasound gel
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 |
|---|---|---|
| Ultrasonography of the tracheaUltrasonographic measurement of the minimal transverse tracheal diameter | Procedure or surgery | Elective pediatric surgery |
Primary outcome
Not reported in the source record.
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 17 Feb 2012.
Related trials for Uncuffed Endotracheal Intubation
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Konstanze Plaschke, Professor study chair
Heidelberg University
Christoph Schramm, MD principal investigator
Heidelberg University
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 Uncuffed Endotracheal Intubation, run by Heidelberg University at 1 site in Germany.
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 2 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 17 Feb 2012. 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 Germany. 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.
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 17 Feb 2012.