Intubation With Uncuffed Endotracheal TubeSoTu2NCT01877980
Ultrasound and Pediatric Endotracheal Tube Size
An observational study of Intubation With Uncuffed Endotracheal Tube, run by Heidelberg University at 1 site in Germany.
Trial summary
The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Intubation With Uncuffed Endotracheal Tube
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Sep 2013
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children scheduled for elective surgery
Who may be able to join
- signed informed consent by the legal guadian
- 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: Prediction of Uncuffed Endotracheal Tube Size in a Pediatric Population by Sonographic Measurements at Various Structures of the Airway Compared to Age-related Formulas and Little-finger Diameters
The aim of the present study was to evaluate the ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger.
Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures.
The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal transverse airway Diameter (MTAD)
In this study measurements of MTAD are performed at three predefined anatomic structures of the airway with each of these at two airway pressures in the time frame between the administration of muscle relaxant and Intubation (average time available 3min).
Measured: Between administration of muscle relaxant and intubation (3min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation With Uncuffed Endotracheal TubeStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Schramm, M.D., Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877980
- Sponsor's protocol ID
- S021/2013
- Acronym
- SoTu2
- Status last verified
- Dec 2014
- First submitted
- 5 Jun 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Uncuffed Endotracheal Tube Size in a Pediatric Population by Sonographic Measurements at Various Structures of the Airway Compared to Age-related Formulas and Little-finger Diameters
- ClinicalTrials.gov ID
- NCT01877980
- Acronym / sponsor ID
- SoTu2 / S021/2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Jun 2013 (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 ultrasonographic airway measurement in pediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse airway diameter (MTAD) with tube size predicted by different age-related formulas and diameter of little finger.
Previous studies already showed that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTAD. In this study measurements are performed at three predefined anatomic structures of the airway with each of These at two airway pressures.
The investigators hypothesize that one of the specific measurements predicts the fitting ETT size better than age-related formulas or diameter of little finger.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children scheduled for elective surgery
Key inclusion criteria (2 listed)
- signed informed consent by the legal guadian
- 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.
Primary outcome
Minimal transverse airway Diameter (MTAD)
Time frame: Between administration of muscle relaxant and intubation (3min)
In this study measurements of MTAD are performed at three predefined anatomic structures of the airway with each of these at two airway pressures in the time frame between the administration of muscle relaxant and Intubation (average time available 3min).
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 3 Dec 2014.
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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 Intubation With Uncuffed Endotracheal Tube, 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 2 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 3 Dec 2014. 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.
What does the primary outcome measure?
Minimal transverse airway Diameter (MTAD) (time frame: Between administration of muscle relaxant and intubation (3min)). 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 3 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.