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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasotracheal Intubation
• Intervention / Treatment: Device: Portex; Device: Mallinckrodt

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyun Joo Kim, MD; Phone Number: 82-2-2224-1389; Email: JJOLLONG@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    • Contact: Hyun Joo Kim, MD; Phone Number: 82-2-2224-1389; Email: JJOLLONG@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portex; usage of PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube	Device: Portex; nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.
Active Comparator: Mallinckrodt; usage of Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube	Device: Mallinckrodt; nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position	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).; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The adequacy of nasotracheal tube cuff location in extended and flexed neck position	whether the tube cuff is located below the vocal cords in 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
The adequacy of nasotracheal tube length	whether the tube cuff cannot be located 3cm below the vocal cords owing to short length of nasotracheal tube.	1 minute after nasotracheal intubation

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 4-2020-0654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No