BronchusNCT02975830
Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements
An observational study of Bronchus and Pediatric Airway, run by King Fahad Medical City.
Trial summary
Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these… Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Bronchus, Pediatric Airway
- What is being tested?
- Three dimensional CT based images
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: upto 8years of age
Who may be able to join
- CT scans airways
Who cannot join
- any disease that is anticipated to distort the normal shape of airways wee excluded from the study
About this study
Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these angles tend to be similar in children younger than three years of ageThe visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway.
We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.
Read the detailed description
Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children.
Significant variations and discrepancies in the reported tracheobronchial angles are found in literature.
Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have been used for measuring the tracheobronchial angles in children and the results are varied with some studies reporting equal angles [2016] while others reporting right bronchial angle to be smaller than left bronchial angle [Kubota].
The visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway. The highest quality medical-grade (3D) images are obtained using CT data [Uchida M]. Computed tomography (CT) is considered the current gold standard for airway measurements as the air-tissue interface is better delineated by CT imaging [Reinhardt].
We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.
- Conditions
- Bronchus, Pediatric Airway
- Being tested
- Three dimensional CT based images
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional CT based imagesRadiation
Right bronchial angle, left bronchial angle
| Study group | Role | What they receive |
|---|---|---|
| 0-2 years | Children aged from birth to 24 months Three dimensional CT based images Receives: Radiation: Three dimensional CT based images | |
| 2-4 Years | Children aged from 25-48 months Three dimensional CT based images Receives: Radiation: Three dimensional CT based images | |
| 4-6 Years | Children aged from 49-72 Three dimensional CT based images Receives: Radiation: Three dimensional CT based images | |
| 6-8 years | Children aged from 73-96 months Three dimensional CT based images Receives: Radiation: Three dimensional CT based images |
What is being measured
The primary outcome is the main question the study is designed to answer.
tracheobronchial angles
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchusStudies 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
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tariq Wani, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975830
- Sponsor's protocol ID
- H-01-R-012/16-460
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements
- ClinicalTrials.gov ID
- NCT02975830
- Acronym / sponsor ID
- H-01-R-012/16-460
- Conditions
- Bronchus, Pediatric Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Nov 2016 (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.
Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these angles tend to be similar in children younger than three years of ageThe visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway.
We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.
Detailed description
Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children.
Significant variations and discrepancies in the reported tracheobronchial angles are found in literature.
Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have been used for measuring the tracheobronchial angles in children and the results are varied with some studies reporting equal angles [2016] while others reporting right bronchial angle to be smaller than left bronchial angle [Kubota].
The visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway. The highest quality medical-grade (3D) images are obtained using CT data [Uchida M]. Computed tomography (CT) is considered the current gold standard for airway measurements as the air-tissue interface is better delineated by CT imaging [Reinhardt].
We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0-2 years | – | Radiation: Three dimensional CT based imagesChildren aged from birth to 24 months Three dimensional CT based images |
| 2-4 Years | – | Radiation: Three dimensional CT based imagesChildren aged from 25-48 months Three dimensional CT based images |
| 4-6 Years | – | Radiation: Three dimensional CT based imagesChildren aged from 49-72 Three dimensional CT based images |
| 6-8 years | – | Radiation: Three dimensional CT based imagesChildren aged from 73-96 months Three dimensional CT based images |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- upto 8years of age
Key inclusion criteria (1 listed)
- CT scans airways
Key exclusion criteria (1 listed)
- any disease that is anticipated to distort the normal shape of airways wee excluded from the study
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 |
|---|---|---|
| Three dimensional CT based imagesRight bronchial angle, left bronchial angle | Radiation | 0-2 years, 2-4 Years, 4-6 Years, 6-8 years |
Primary outcome
tracheobronchial angles
Time frame: 6 months
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 4 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchus and Pediatric Airway, run by King Fahad Medical City.
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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
tracheobronchial angles (time frame: 6 months). 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 4 Jan 2017.