ChildNCT02925169
Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging
An observational study of Child, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region. This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Child
- What is being tested?
- CT Scan
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2016to Oct 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 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 12 months of age
Who may be able to join
- Neonates and infants.
Who cannot join
- Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.
This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.
Read the detailed description
Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.
This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.
- Conditions
- Child
- Being tested
- CT Scan
- Keywords
- Subglottis, cricoid, airway shape, CT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanDevice
CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Shape of airway in neonates and infants
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChildStudies 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
- 40 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
- Investigators
- Tariq Wani, MD, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925169
- Sponsor's protocol ID
- H-01-R-012
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wani TM, Bissonnette B, Rafiq Malik M, Hayes D Jr, Ramesh AS, Al Sohaibani M, Tobias JD. Age-based analysis of pediatric upper airway dimensions using computed tomography imaging. Pediatr Pulmonol. 2016 Mar;51(3):267-71. doi: 10.1002/ppul.23232. Epub 2015 Jun 17.
PubMed 26083203Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. doi: 10.1017/s0022215100113416.
PubMed 2230557Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.
PubMed 12502977
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging
- ClinicalTrials.gov ID
- NCT02925169
- Acronym / sponsor ID
- H-01-R-012
- Conditions
- Child
- Keywords
- Subglottis, cricoid, airway shape, CT imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Oct 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.
Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.
This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.
Detailed description
Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.
This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 12 months of age
Key inclusion criteria (1 listed)
- Neonates and infants.
Key exclusion criteria (1 listed)
- Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases
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 |
|---|---|---|
| CT ScanCT imaging | Device | – |
Primary outcome
Shape of airway in neonates and infants
Time frame: 1 month
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 5 Oct 2016.
- Background: PubMed 26083203Wani TM, Bissonnette B, Rafiq Malik M, Hayes D Jr, Ramesh AS, Al Sohaibani M, Tobias JD. Age-based analysis of pediatric upper airway dimensions using computed tomography imaging. Pediatr Pulmonol. 2016 Mar;51(3):267-71. doi: 10.1002/ppul.23232. Epub 2015 Jun 17.
- Background: PubMed 2230557Sellars I, Keen EN. Laryngeal growth in infancy. J Laryngol Otol. 1990 Aug;104(8):622-5. doi: 10.1017/s0022215100113416.
- Background: PubMed 12502977Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.
- 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.
Tariq Wani, MD principal investigator
King Fahad Medical City
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 Child, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 5 Oct 2016. 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 Saudi Arabia. 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?
Shape of airway in neonates and infants (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925169, which also lists 3 linked publications.
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 5 Oct 2016.