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

NCT ID: NCT06618625

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

80 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 tube rotation on passage of the tracheal tube through the nasopharynx into the oral cavity in nasotracheal intubation.

Detailed Description

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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.

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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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.

Group Type EXPERIMENTAL

nasotracheal intubation

Intervention Type PROCEDURE

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.

Neutral

For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.

Group Type ACTIVE_COMPARATOR

nasotracheal intubation

Intervention Type PROCEDURE

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.

Interventions

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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.

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 nose
* current severe epistaxis
* limitation of neck extension
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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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.

Reference Type BACKGROUND
PMID: 31421677 (View on PubMed)

Other Identifiers

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10-2023-61

Identifier Type: -

Identifier Source: org_study_id

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