CT Analysis of the Anatomy of the Nasotracheal Intubation Pathway of Patients With Indication of Maxillary Advancement

January 25, 2019 updated by: Cagil Vural, Ankara University

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

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

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06560
        • Ankara University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgery with indication of maxillary advancement.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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