- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570528
CT Analysis of the Anatomy of the Nasotracheal Intubation Pathway of Patients With Indication of Maxillary Advancement
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06560
- Ankara University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
CT data of patients with indications for maxillary advancement surgery will be included in the study.
Exclusion Criteria:
CT images without nasal cavities will not be included in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Maxillary Retrusion
CT
|
Healthy Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tube Size
Time Frame: 2 months
|
Minimum nasotracheal tube sizes will be calculated (mm).
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intubation
-
Spanish Network for Research in Infectious DiseasesCompletedIntubation | Intubation Complication | Intubation; Difficult or FailedSpain
-
University Hospital, Clermont-FerrandSociété Française d'Anesthésie-Réanimation (SFAR)Not yet recruitingEndotracheal Intubation | Intubation Complication | Intubation; Difficult or Failed
-
Emory UniversityTerminatedAirway Morbidity | Intubation Complication | Anesthesia Intubation Complication | Tracheal Intubation Morbidity | Failed or Difficult Intubation, SequelaUnited States
-
Catharina Ziekenhuis EindhovenCompletedAnesthesia Intubation Complication | Intubation; Difficult | Failed or Difficult Intubation | Failed or Difficult Intubation, Initial EncounterNetherlands
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
University Hospital HeidelbergRecruitingIntubation | Intubation ComplicationGermany
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)RecruitingIntubation Complication | Intubation; Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Japan, Italy, New Zealand, Singapore, Australia, Austria, Germany, India, United Kingdom
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedIntubation, Nasotracheal IntubationTaiwan
-
University at BuffaloTerminatedIntubation Complication | Intubation;DifficultUnited States
-
University Hospitals Coventry and Warwickshire...Oxford University Hospitals NHS TrustCompletedIntubation;Difficult | Tracheal IntubationUnited Kingdom