Tube Rotation for Tube Passage Into the Oral Cavity in Nasotracheal Intubation

Not Applicable

Not yet recruiting

• Conditions: Nasotracheal Intubation
• Interventions: Procedure: nasotracheal intubation

• Registration Number: NCT06618625
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of the study is to investigate the effect of tube rotation on passage of the tracheal tube through the nasopharynx into the oral cavity in nasotracheal intubation.

Detailed Description

This prospective randomized controlled study was approved by IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility of the study. Then, patients will be randomized to one of two groups; (group I: tube advancement in neutral / group II: tube advancement with the tube counter-clockwise rotated). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via a nostril approximately 3-4 cm. Next, an anesthesiologist will advance the tube, with it neutral, continuously into the oral cavity of the patients in Group I, while the anesthesiologist will advance the tube, with it rotated counter-clockwise in 90 degree, into the oral cavity of the patients in Group II. After the tube will be placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtainment of all data, investigators will analyze incidence of epistaxis and its severity between two groups.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-23
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-08-22
• Study Completion: 2025-09-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• adult patients requiring nasotracheal intubation for elective surgery

Exclusion Criteria

• refuse to participate in the study
• severe deformity in nose
• current severe epistaxis
• limitation of neck extension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral	nasotracheal intubation	For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.
Rotation	nasotracheal intubation	For nasotracheal intubation, the nasal RAE tube will be inserted with it rotated by 90 degrees in counter-clockwise direction for patients in the 'Rotation' arm.

Primary Outcome Measures

Name	Time	Method
tube blockade	during tube advancement from the nasal cavity to the oral cavity	tube blockade when an anesthesiologist is advancing the tracheal tube from the nasal cavity to the oral cavity.

Secondary Outcome Measures

Name	Time	Method
epistaxis	during nasotracheal intubation	epistaxis due to nasotracheal intubation