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

Not Applicable

Not yet recruiting

• Conditions: Nasotracheal Intubation
• Interventions: Device: Mallinckrodt; Device: Portex

• Registration Number: NCT04499222
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Study Start: 2020-08
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05
• Primary Completion: 2022-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mallinckrodt	Mallinckrodt	usage of Mallinckrodt TaperGuard \[Covidien, Ireland\] nasotracheal tube
Portex	Portex	usage of PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\] nasotracheal tube

Primary Outcome Measures

Name	Time	Method
The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position	1 minute after nasotracheal intubation	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of