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

The Effect of Tube Rotation on Passage of Tracheal Tube Through Nasopharynx Into the Oral Cavity in Nasotracheal Intubation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Man Lee, M.D., Ph.D.; Phone Number: +82-2-870-2513; Email: jungman007@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotation; 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.	Procedure: 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. For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.
Active Comparator: Neutral; For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.	Procedure: 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. For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tube blockade	tube blockade when an anesthesiologist is advancing the tracheal tube from the nasal cavity to the oral cavity.	during tube advancement from the nasal cavity to the oral cavity

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epistaxis	epistaxis due to nasotracheal intubation	during nasotracheal intubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.

Study record dates

Study Major Dates

• Study Start (Estimated): September 23, 2024
• Primary Completion (Estimated): August 22, 2025
• Study Completion (Estimated): September 22, 2025

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 10-2023-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No