Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes

NCT ID: NCT04499222

Last Updated: 2020-08-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2025-05-31

Brief Summary

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The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\], Mallinckrodt TaperGuard \[Covidien, Ireland\]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.

Detailed Description

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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

NONE

Study Groups

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Portex

usage of PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\] nasotracheal tube

Group Type EXPERIMENTAL

Portex

Intervention Type DEVICE

nasotracheal intubation with PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\] nasotracheal tube.

Mallinckrodt

usage of Mallinckrodt TaperGuard \[Covidien, Ireland\] nasotracheal tube

Group Type ACTIVE_COMPARATOR

Mallinckrodt

Intervention Type DEVICE

nasotracheal intubation with Mallinckrodt TaperGuard \[Covidien, Ireland\] nasotracheal tube.

Interventions

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Portex

nasotracheal intubation with PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\] nasotracheal tube.

Intervention Type DEVICE

Mallinckrodt

nasotracheal intubation with Mallinckrodt TaperGuard \[Covidien, Ireland\] nasotracheal tube.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation

Exclusion Criteria

1. Patients under 20 years old
2. Patients with ASA class IV or higher
3. Pregnant women
4. Patients receiving emergency surgery
5. Patients who have nasal disease or who undergo nose surgery because of nasal disease
6. Patient with craniofacial anomaly
7. Patients with impaired cervical motion
8. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
9. Patients who refused the clinical trial Patients with dementia or cognitive impairment
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hyun Joo Kim, MD

Role: CONTACT

82-2-2224-1389

Facility Contacts

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Hyun Joo Kim, MD

Role: primary

82-2-2224-1389

Other Identifiers

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4-2020-0654

Identifier Type: -

Identifier Source: org_study_id

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