Nostril Side on Epistaxis

NCT ID: NCT06605989

Last Updated: 2024-10-01

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-09-22

Brief Summary

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The purpose of the study is to investigate the effect of the nostril side on epistaxis during nasotracheal intubation.

Detailed Description

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

Patients requiring nasotracheal intubation will be screened for eligibility for the study. Then, patients will be randomized to one of two groups; (Group I: tube will be inserted through the left nostril and advanced into the oral cavity / Group II: tube will be inserted through the right nostril and advanced into the oral cavity). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. Next, an anesthesiologist will advance the tube into the oral cavity. After the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.

Conditions

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Nasotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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left nostril side

For nasotracheal intubation, the nasal RAE tube will be inserted through the left nostril and advanced into the oral cavity.

Group Type EXPERIMENTAL

Nasotracheal intubation

Intervention Type PROCEDURE

For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm. For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.

right nostril side

For nasotracheal intubation, the nasal RAE tube will be inserted through the right nostril and advanced into the oral cavity.

Group Type EXPERIMENTAL

Nasotracheal intubation

Intervention Type PROCEDURE

For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm. For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.

Interventions

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Nasotracheal intubation

For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm. For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult patients requiring nasotracheal intubation for elective surgery

Exclusion Criteria

* refuse to participate in the study
* severe deformity in the nose
* current severe epistaxis
* cannot insert the tube into a specific nostril side due to any reason
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jung-Man Lee, M.D., Ph.D.

Role: CONTACT

+82-2-870-2513

References

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Sanuki T, Hirokane M, Kotani J. Epistaxis during nasotracheal intubation: a comparison of nostril sides. J Oral Maxillofac Surg. 2010 Mar;68(3):618-21. doi: 10.1016/j.joms.2009.04.097. Epub 2009 Nov 22.

Reference Type BACKGROUND
PMID: 19931965 (View on PubMed)

Other Identifiers

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04-2024-0025

Identifier Type: -

Identifier Source: org_study_id

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