Cone Beam Computed Tomography For Appropriate Nostril Selection for Nasotracheal Intubation

NCT06247969 | Completed

• 1 other identifier: F001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.Exclusion Criteria: Unsuccessful nasotracheal intubation, difficult mask, and/or difficult intubation.
5. 5.Implementation and Evaluation: Anesthesia procedures and CBCT evaluations will be carried out by experienced specialists.
6. 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.

Conditions

Intubation; Difficult or Failed; Intubation Complication

Keywords

cone-beam computed tomography; intubation; nasal cavity; nasal septum; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients intubated under general anesthesia via nasotracheal route.

Patients intubated under general anesthesia via nasotracheal route successfully.

Device: endotracheal tube

Interventions

endotracheal tube 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.

Patients intubated under general anesthesia via nasotracheal route.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population in this study consists ASA I-II patients, aged 18-70 years old, who had undergone maxillofacial surgery under general anesthesia with nasotracheal intubation and had undergone CBCT examination of maxillofacial area for various reasons before the operation.

You may qualify if:

• ASA I-II patients

You may not qualify if:

• Clinical diagnosis of allergic rhinitis
• Patient with structural abnormalities in maxillo-mandibular anatomy,
• Patient with limited mouth opening
• Patient has previous history of epistaxis

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Dentistry

Konya, 42130, Turkey (Türkiye)

Location

Study Officials

• FUNDA ARUN

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 8, 2024
• Study Start: December 19, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 5, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

TU (1)