Airway ManagementNCT02771171
Volumetric Three-dimensional Analysis of the Pediatric Upper Airway Shape Using Computed Tomography Imaging.
An observational study of Airway Management, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
CT and MRI based measurements of the pediatric airway has changed the age-old cone shape concept of the pediatric airway and define airway shape as elliptical structure. The cone shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by Eckenhoff in 1951. Read more about this study
- Who is it for?
- Ages 1 month to 96 months
- Conditions the study is for
- Airway Management
- What is being tested?
- CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2016to Aug 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
- No healthy volunteers
- Child
Study population: Children aged 1 month to 8 years undergoing radiological evaluation (CT Imaging) unrelated to airways symptomatology
Who may be able to join
None listed.
Who cannot join
- Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases Patients with poor image quality were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
CT and MRI based measurements of the pediatric airway has changed the age-old cone shape concept of the pediatric airway and define airway shape as elliptical structure. The cone shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by Eckenhoff in 1951.
The present study is based on three-dimensional CT images of the airway column replicating the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was to determine the cone shape of the pediatric airway.
Read the detailed description
This is a retrospective review of three-dimensional CT air column images of 60 children aged 1 month to 8 years undergoing radiological evaluation unrelated to airways symptomatology. The CT scans will be evaluated in children either sleeping naturally or sedated throughout the study period. Volumetric analysis of the air-column was done at the level of cricoid, subglottis and trachea
Exclusion Criteria:
Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases.
Patients with poor image quality were also excluded from the study.
- Conditions
- Airway Management
- Being tested
- CT Scan
- Keywords
- Pediatric Airway, Three-dimensional Imaging, CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanRadiation
CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Age groups | The cohort is divided into on the basis of age Receives: Radiation: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shape of the pediatric Airway
The purpose of this study was to determine the shape of pediatric airway from subglottis to the trachea using 3D dimensional CT air column images. The shape of the airway was calculated on the basis of the volumes of airway column at the level of subglottis, cricoid and trachea
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 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 Airway ManagementStudies 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
- 60 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
- Joseph D Tobias, MD, Study director, Nationwide Children's Hospital, Columbus, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771171
- Sponsor's protocol ID
- IRB
- Status last verified
- Aug 2016
- First submitted
- 11 May 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
ECKENHOFF JE. Some anatomic considerations of the infant larynx influencing endotracheal anesthesia. Anesthesiology. 1951 Jul;12(4):401-10. doi: 10.1097/00000542-195107000-00001. No abstract available.
PubMed 14847223Wani 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 26083203Litman 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 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Three-dimensional Analysis of the Pediatric Upper Airway Shape Using Computed Tomography Imaging.
- ClinicalTrials.gov ID
- NCT02771171
- Acronym / sponsor ID
- IRB
- Conditions
- Airway Management
- Keywords
- Pediatric Airway, Three-dimensional Imaging, CT Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 May 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.
CT and MRI based measurements of the pediatric airway has changed the age-old cone shape concept of the pediatric airway and define airway shape as elliptical structure. The cone shape was based on the cadaveric measurements done by Bayeux in 1897 and described later by Eckenhoff in 1951.
The present study is based on three-dimensional CT images of the airway column replicating the cylinders used by Bayeux for his cadaveric measurements. The purpose of this study was to determine the cone shape of the pediatric airway.
Detailed description
This is a retrospective review of three-dimensional CT air column images of 60 children aged 1 month to 8 years undergoing radiological evaluation unrelated to airways symptomatology. The CT scans will be evaluated in children either sleeping naturally or sedated throughout the study period. Volumetric analysis of the air-column was done at the level of cricoid, subglottis and trachea
Exclusion Criteria:
Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases.
Patients with poor image quality were also excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age groups | – | Radiation: CT ScanThe cohort is divided into on the basis of age |
Who may qualify
- Ages
- 1 month to 96 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 month to 8 years undergoing radiological evaluation (CT Imaging) unrelated to airways symptomatology
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with a tracheostomy or endotracheal tube in place, tracheo-esophageal fistula, pulmonary collapse or atelectasis, mediastinal mass, diaphragmatic hernia, extrapulmonary and intrathoracic mass, preterm infants, and patients with genetic syndromes and primary lung diseases Patients with poor image quality were also 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 |
|---|---|---|
| CT ScanCT imaging | Radiation | Age groups |
Primary outcome
Shape of the pediatric Airway
Time frame: 12 months
The purpose of this study was to determine the shape of pediatric airway from subglottis to the trachea using 3D dimensional CT air column images. The shape of the airway was calculated on the basis of the volumes of airway column at the level of subglottis, cricoid and trachea
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 30 Aug 2016.
- Background: PubMed 14847223ECKENHOFF JE. Some anatomic considerations of the infant larynx influencing endotracheal anesthesia. Anesthesiology. 1951 Jul;12(4):401-10. doi: 10.1097/00000542-195107000-00001. No abstract available.
- Results publication: 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.
- Results publication: 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: Yes
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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.
Joseph D Tobias, MD study director
Nationwide Children's Hospital, Columbus, Ohio
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 Airway Management, 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 0 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 30 Aug 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 the pediatric Airway (time frame: 12 months). 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 NCT02771171, 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 30 Aug 2016.