Maxillary HypoplasiaNCT03570528
CT Analysis of the Anatomy of the Nasotracheal Intubation Pathway of Patients With Indication of Maxillary Advancement
An observational study of Maxillary Hypoplasia and Retrognathia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Differences in nasotracheal intubation pathway anatomy will be observed between healthy patients and patients with maxillary retrusion. The results will clarify the nasotracheal intubation tube preference for these patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Hypoplasia, Retrognathia, Intubation
- How many people
- 187 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2018to 1 Sep 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who underwent surgery with indication of maxillary advancement.
Who may be able to join
- CT data of patients with indications for maxillary advancement surgery will be included in the study.
Who cannot join
- CT images without nasal cavities will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06560
About this study
Official title: Retrospective Analysis of the Differences in the Anatomy of the Nasotracheal Intubation Pathway With Computerized Tomography of Patients With Indication of Maxillary Advancement
Differences in nasotracheal intubation pathway anatomy will be observed between healthy patients and patients with maxillary retrusion.
The results will clarify the nasotracheal intubation tube preference for these patients.
Read the detailed description
A combination of many factors affecting growth and development creates dento-facial deformities. One of these deformities may be defined as maxillary retrusion defined as inadequate maxillary development . The maxilla's sagittal skeletal deficiencies cause functional problems such as respiratory and nutritional difficulties in addition to aesthetic problems and often require surgical treatment.
These surgeries are done under general anesthesia. Nasotracheal intubation is used during these surgeries to provide general anesthesia. During nasotracheal intubation, there are two different pathways (upper and lower) in which the tracheal tube can advance through the nostrils.
The lower tract extends along the nasal floor and lies beneath the lower concha. Concha nasalis inferior is a thin and independent viscerocranium bone and articulates with the face of the maxillary and palatine bone facing the nasal cavity of the vertical lamina. The free lower edge of the concha nasalis inferior is oriented downwards towards the nasal cavity, restricting the meatus inferior. The inferior of the meatus is the largest and extends along the length of the outer wall of the nasal cavity. The area where the part between the first ⅓ and the middle ⅓ meets is the widest area of meatus nasi medius and there is the openness of the nasolacrimal channel. In the lower opening of the nasolacrimal duct, there may be an indeterminate mucosa layer formed by the mucous membrane of the nasal cavity, which is called Hasner cap.
The upper pathway is located just below the middle concha over the lower concha. Concha nasal is medius is a segment extending medially from the ethmoid bone and may sometimes contain one or more of the ethmoid air cells. Concha nasalis medius extends to the posterior and articulates with a vertical laminate of palatine bone. Below Concha nasalis medius is called meatus nasi medius and narrows from front to back. The widest area of the beginning of meatus nasi medius, just above the vestibulum, is called the atrium meatus medii. There are many paranasal sinuses in Meatus nasi medius; frontal sinus, anterior and middle group ethmoid sinuses and maxillary sinus opens here. At the extreme end of the Meatus nasi medius, there are foramen sphenopalatinum, which vessels and nerves related to the nasal cavity enter this gap.
The lower pathway is referred to as a safer road than the upper pathway, since it is located remote from the middle concha and from the cribriform layer. The trauma to the middle concha may cause avulsions and large bleedings. Trauma to the cribriform plate may also cause cerebrospinal fluid rhinoresin or olfactory nerve damage. These conditions will be especially important in anatomic variations, such as in middle concha hypertrophy and concha bullosa.
The fact that the anesthetist has knowledge of the regional anatomy and the ability to choose the appropriate size of the intubation canal is important for preventing these complications. The purpose of the current study is to study complete head tomography images for patients with maxillary retrusions and evaluate bone and soft tissue anatomy and reveal the differences which can be found in airway size and to use intubation tubes accordingly to these data.
Eight different parameters, including diameter measurements for two different intubation routes,in right / left separation, male / female separation and patient / control group separation will be evaluated.
In the study, effect size (f) = 0.275, α = 0.05, β = 0.80 and 1-and 80% at 95% confidence theoretical power for each group in this study 100 d enek is calculated. Investigators aimed to study the patient capacity of the department with a minimum of 51 patients in each group.
The data for the study will be evaluated by the licensed SPSS 21.0 package program. Student's t test and / or Mann-Whitney U test in two-group comparisons and Anova and / or Kruskall-Wallis H test in three or more group comparisons as a result of normality tests of the data. Correlation analysis or chi-square dependence tests will be used to relate variables according to the level of measurement of the data. For the intra-observer reliability, the Kap p a compliance test will be used. It should be stated that there is no significant difference when p> 0,05 and when p <0,05 meaningful difference will be indicated.
- Conditions
- Maxillary Hypoplasia, Retrognathia, Intubation, Tomography
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary Retrusion | CT | |
| Healthy Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube Size
Minimum nasotracheal tube sizes will be calculated (mm).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start20 May 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary HypoplasiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagil Vural, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570528
- Sponsor's protocol ID
- 08/03
- Status last verified
- Jan 2019
- First submitted
- 18 Jun 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Differences in the Anatomy of the Nasotracheal Intubation Pathway With Computerized Tomography of Patients With Indication of Maxillary Advancement
- ClinicalTrials.gov ID
- NCT03570528
- Acronym / sponsor ID
- 08/03
- Conditions
- Maxillary Hypoplasia, Retrognathia, Intubation, Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 27 Jun 2018 (actual)
- 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.
Differences in nasotracheal intubation pathway anatomy will be observed between healthy patients and patients with maxillary retrusion.
The results will clarify the nasotracheal intubation tube preference for these patients.
Detailed description
A combination of many factors affecting growth and development creates dento-facial deformities. One of these deformities may be defined as maxillary retrusion defined as inadequate maxillary development . The maxilla's sagittal skeletal deficiencies cause functional problems such as respiratory and nutritional difficulties in addition to aesthetic problems and often require surgical treatment.
These surgeries are done under general anesthesia. Nasotracheal intubation is used during these surgeries to provide general anesthesia. During nasotracheal intubation, there are two different pathways (upper and lower) in which the tracheal tube can advance through the nostrils.
The lower tract extends along the nasal floor and lies beneath the lower concha. Concha nasalis inferior is a thin and independent viscerocranium bone and articulates with the face of the maxillary and palatine bone facing the nasal cavity of the vertical lamina. The free lower edge of the concha nasalis inferior is oriented downwards towards the nasal cavity, restricting the meatus inferior. The inferior of the meatus is the largest and extends along the length of the outer wall of the nasal cavity. The area where the part between the first ⅓ and the middle ⅓ meets is the widest area of meatus nasi medius and there is the openness of the nasolacrimal channel. In the lower opening of the nasolacrimal duct, there may be an indeterminate mucosa layer formed by the mucous membrane of the nasal cavity, which is called Hasner cap.
The upper pathway is located just below the middle concha over the lower concha. Concha nasal is medius is a segment extending medially from the ethmoid bone and may sometimes contain one or more of the ethmoid air cells. Concha nasalis medius extends to the posterior and articulates with a vertical laminate of palatine bone. Below Concha nasalis medius is called meatus nasi medius and narrows from front to back. The widest area of the beginning of meatus nasi medius, just above the vestibulum, is called the atrium meatus medii. There are many paranasal sinuses in Meatus nasi medius; frontal sinus, anterior and middle group ethmoid sinuses and maxillary sinus opens here. At the extreme end of the Meatus nasi medius, there are foramen sphenopalatinum, which vessels and nerves related to the nasal cavity enter this gap.
The lower pathway is referred to as a safer road than the upper pathway, since it is located remote from the middle concha and from the cribriform layer. The trauma to the middle concha may cause avulsions and large bleedings. Trauma to the cribriform plate may also cause cerebrospinal fluid rhinoresin or olfactory nerve damage. These conditions will be especially important in anatomic variations, such as in middle concha hypertrophy and concha bullosa.
The fact that the anesthetist has knowledge of the regional anatomy and the ability to choose the appropriate size of the intubation canal is important for preventing these complications. The purpose of the current study is to study complete head tomography images for patients with maxillary retrusions and evaluate bone and soft tissue anatomy and reveal the differences which can be found in airway size and to use intubation tubes accordingly to these data.
Eight different parameters, including diameter measurements for two different intubation routes,in right / left separation, male / female separation and patient / control group separation will be evaluated.
In the study, effect size (f) = 0.275, α = 0.05, β = 0.80 and 1-and 80% at 95% confidence theoretical power for each group in this study 100 d enek is calculated. Investigators aimed to study the patient capacity of the department with a minimum of 51 patients in each group.
The data for the study will be evaluated by the licensed SPSS 21.0 package program. Student's t test and / or Mann-Whitney U test in two-group comparisons and Anova and / or Kruskall-Wallis H test in three or more group comparisons as a result of normality tests of the data. Correlation analysis or chi-square dependence tests will be used to relate variables according to the level of measurement of the data. For the intra-observer reliability, the Kap p a compliance test will be used. It should be stated that there is no significant difference when p> 0,05 and when p <0,05 meaningful difference will be indicated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary Retrusion | – | –CT |
| Healthy Patients | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who underwent surgery with indication of maxillary advancement.
Key inclusion criteria (1 listed)
- CT data of patients with indications for maxillary advancement surgery will be included in the study.
Key exclusion criteria (1 listed)
- CT images without nasal cavities will not be included in 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.
Primary outcome
Tube Size
Time frame: 2 months
Minimum nasotracheal tube sizes will be calculated (mm).
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 28 Jan 2019.
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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 Maxillary Hypoplasia and Retrognathia, run by Ankara University at 1 site in Turkey (Türkiye).
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 28 Jan 2019. 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 Turkey (Türkiye). 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?
Tube Size (time frame: 2 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 28 Jan 2019.