Cone Beam Computed Tomography For Appropriate Nostril Selection for Nasotracheal Intubation

Intubation Complication Clinical Trial

Official title:

Using Cone Beam Computed Tomography For Appropriate Nostril Selection In Nasotracheal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06247969
• Other study ID #: F001
• Status: Completed
• Start date: December 19, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: April 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Design: Nasotracheal intubation is a standard blind procedure associated with various complications. Selection of the appropriate nostril is crucial in preventing most of these complications. The investigators aimed to evaluate the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation.

Methods: This prospective observational study outlines the protocol for research conducted at the Selçuk University Faculty of Dentistry.

Scope of the Research: The study encompasses patients undergoing dental surgery under general anesthesia at the Selçuk University Faculty of Dentistry.

1. Participant Selection: ASA I-II patients will be included in the study. Patients with structural abnormalities in the maxillo-mandibular anatomy, limited mouth opening, comorbidities such as rheumatoid arthritis, and a history of epistaxis will be excluded from the study.

2. Anesthesia Method: General anesthesia induction will be performed with intravenous (IV) propofol, IV rocuronium bromide, and IV fentanyl. Transition to nasotracheal intubation will follow adequate mask ventilation, and the preferred nostril will be determined through a simple occlusion test.

3. Data Collection: Demographic data, accompanying illnesses, medications used, and various parameters related to nasotracheal intubation will be recorded. The anesthetist performing nasotracheal intubation will be blinded to CBCT data, and the evaluation of data will be conducted jointly by the anesthetist and Radiology specialist after data collection from all patients is complete.

4. Exclusion Criteria: Unsuccessful nasotracheal intubation, difficult mask, and/or difficult intubation.

5. Implementation and Evaluation: Anesthesia procedures and CBCT evaluations will be carried out by experienced specialists.

6. The objective of this study is to evaluate the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia. The statistical tests to be employed are the chi-squared test and independent samples t-test.

Description:

The goal of this prospective observational study is the contribution of CBCT findings in selecting the proper nostril for nasotracheal intubation. The main question it aim to answer is:

1. Can pre-operative evaluations of participiants' nasal cavity by using CBCT aid anesthetists for selecting the appropriate nostril for nasotracheal intubation? The participants will be informed both through a written consent form, and verbally that they would be participating in the observational study, and that apart from routine procedures, no additional interventions would be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 5, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA I-II patients

Exclusion Criteria:

• Clinical diagnosis of allergic rhinitis

• Patient with structural abnormalities in maxillo-mandibular anatomy,

• Patient with limited mouth opening

• Patient has previous history of epistaxis

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Intervention

Device:
• endotracheal tube
Endotracheal Tube (ETT) is a flexible plastic tube that is inserted through the mouth or nose into the trachea to establish an artificial airway.

Locations

Country	Name	City	State
Turkey	Selcuk University Faculty of Dentistry	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation the use of preoperative measurements of the nasal cavity from CBCT images in selecting the appropriate nostril for nasotracheal intubation under general anesthesia.	The proper selection of the nostril is crucial in preventing complications such as bleeding associated with nasotracheal intubation. In this regard, we investigated the potential utility of Cone Beam Computed Tomography (CBCT), a commonly available imaging method in dental hospitals, as an assisting tool for anesthetists.	4 weeks