Cone Beam Computed Tomography For Appropriate Nostril Selection for Nasotracheal Intubation

NCT ID: NCT06247969

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2024-02-05

Brief 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.

Detailed 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.

Conditions

Intubation; Difficult or Failed; Intubation Complication

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients intubated under general anesthesia via nasotracheal route.

Patients intubated under general anesthesia via nasotracheal route successfully.

endotracheal tube

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

FUNDA ARUN

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FUNDA ARUN

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Selcuk University Faculty of Dentistry

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

F001

Identifier Type: -

Identifier Source: org_study_id