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

NCT04499222 | Unknown

• 1 other identifier: 4-2020-0654
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position

  1. whether the tube tip is located above the carina in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position). 2. the distance from the carina to the tube tip in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is fixed 3cm below the vocal cords (in neutral neck position).

  1 minute after nasotracheal intubation

Secondary Outcomes (2)

• The adequacy of nasotracheal tube cuff location in extended and flexed neck position

  1 minute after nasotracheal intubation

• The adequacy of nasotracheal tube length

  1 minute after nasotracheal intubation

Study Arms (2)

Portex

EXPERIMENTAL

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

Device: Portex

Mallinckrodt

ACTIVE COMPARATOR

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

Device: Mallinckrodt

Interventions

Portex DEVICE

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

Portex

Mallinckrodt DEVICE

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

Mallinckrodt

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients under 20 years old
• Patients with ASA class IV or higher
• Pregnant women
• Patients receiving emergency surgery
• Patients who have nasal disease or who undergo nose surgery because of nasal disease
• Patient with craniofacial anomaly
• Patients with impaired cervical motion
• Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
• Patients who refused the clinical trial Patients with dementia or cognitive impairment

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

Central Study Contacts

Hyun Joo Kim, MD

CONTACT

82-2-2224-1389; JJOLLONG@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2025
• Last Updated: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)