The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube

NCT ID: NCT03740620

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-03-31

Brief Summary

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In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

Detailed Description

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Primary outcome

* incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) Secondary outcome
* intubation time
* incidence of epistaxis
* severity of bleeding
* Resistance during Insertion of the tracheal tube

Conditions

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Epistaxis Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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intervention group

In the intervention group, a nasotracheal tube is inserted into the nostril with the bevel of the tube facing the cephalad direction of the patient.

Group Type ACTIVE_COMPARATOR

Bevel facing the cephalad direction of the patient

Intervention Type PROCEDURE

The bevel of the nasotracheal tube facing cephalad direction of the patient

conventional group

In the conventional group, a nasotracheal tube is inserted in a usual way, i.e., with the bevel of the tube facing the left side of the patient.

Group Type ACTIVE_COMPARATOR

Bevel facing leftward of the patient

Intervention Type PROCEDURE

The bevel of the nasotracheal tube facing the left side of the patient

Interventions

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Bevel facing the cephalad direction of the patient

The bevel of the nasotracheal tube facing cephalad direction of the patient

Intervention Type PROCEDURE

Bevel facing leftward of the patient

The bevel of the nasotracheal tube facing the left side of the patient

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a patient who will take operation which needs nasotracheal intubation under general anesthesia

Exclusion Criteria

* a patient who didn't agree to participate in this study
* a patient who has a deformity of the nose
* a patient who has a history of severe epistaxis
* a patient who has coagulation problem
* a patient who has a history of the fracture or surgery of the skull base
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tae Kyong Kim

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Won D, Kim H, Chang JE, Lee JM, Min SW, Jung J, Yang HJ, Hwang JY, Kim TK. Effect of bevel direction on the tracheal tube pathway during nasotracheal intubation: A randomised trial. Eur J Anaesthesiol. 2021 Feb 1;38(2):157-163. doi: 10.1097/EJA.0000000000001347.

Reference Type DERIVED
PMID: 33009189 (View on PubMed)

Other Identifiers

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30-2018-76

Identifier Type: -

Identifier Source: org_study_id

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