LarynxNCT03030781
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
An observational study of Larynx and Oxygen, run by King Fahad Medical City.
Trial summary
Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. Read more about this study
- Who is it for?
- Ages 1 month to 96 monthsHealthy volunteers can take part
- Conditions the study is for
- Larynx, Oxygen, Intubation
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Nov 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 1 month to 96 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The present study evaluated CT images of the chest of children less than 8 years of age. The database search of the electronic medical records identified 110 patients of which 40 patients qualified for the study.
Who may be able to join
- Children 1 month to 8 years of age
Who cannot join
- Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants
About this study
Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. The primary aims of this study were to define the relationship between cricoid and mainstem bronchi (right and left) in children of various ages and to determine the effects of age, height and weight.
Read the detailed description
Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.
Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.
- Conditions
- Larynx, Oxygen, Intubation
- Medical subject headings
- Laryngeal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between cricoid and mainstem borncchi
Measured: 1 month to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LarynxStudies 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
- Retrospective
- Enrolment
- 35 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
- NCT03030781
- Sponsor's protocol ID
- H-01-R-012, 17-010
- Status last verified
- Nov 2016
- First submitted
- 21 Jan 2017
- Last updated
- 25 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 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
- ClinicalTrials.gov ID
- NCT03030781
- Acronym / sponsor ID
- H-01-R-012, 17-010
- Conditions
- Larynx, Oxygen, Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Jan 2017 (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.
Specific and objective guidelines for choosing endobronchial tube size for main-stem intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size for OLV are likely to increase the safety and success. The primary aims of this study were to define the relationship between cricoid and mainstem bronchi (right and left) in children of various ages and to determine the effects of age, height and weight.
Detailed description
Understanding the relationship between cricoid and mainstem bronchi can provide to be a useful adjunct for lung isolation in children. The relationship between cricoid dimensions and the dimensions of main-stem bronchi (right and left) have been studied using 2 dimensional CT images and video-bronchoscopic images. The present study defines the volume-based relationship between the right main-stem bronchus (RMSB), left main-stem bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.
Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing radiological evaluation unrelated to airway symptomatology were examined. The children were evaluated during spontaneous ventilation without airway devices either during natural sleep or with sedation. The 3-dimensional images of the airway column were evaluated at the level of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and comparisons made between these levels. Univariate and multivariate regression analysis was used to determine whether one or more of the variables (age, gender, height, weight and cricoid) had a predictable relationship to the RMSB and the LMSB diameter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 96 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The present study evaluated CT images of the chest of children less than 8 years of age. The database search of the electronic medical records identified 110 patients of which 40 patients qualified for the study.
Key inclusion criteria (1 listed)
- Children 1 month to 8 years of age
Key exclusion criteria (1 listed)
- Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass Diaphragmatic hernia Preterm infants
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
comparison between cricoid and mainstem borncchi
Time frame: 1 month to 8 years
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 25 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 Larynx and Oxygen, 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 25 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?
comparison between cricoid and mainstem borncchi (time frame: 1 month to 8 years). 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 25 Jan 2017.