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

Nasotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04499222
• Other study ID #: 4-2020-0654
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: May 2025

Study information

• Verified date: July 2020
• Source: Yonsei University
• Contact: Hyun Joo Kim, MD
• Phone: 82-2-2224-1389
• Email: JJOLLONG[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasotracheal Intubation

Intervention

Device:
• Portex
nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.
• Mallinckrodt
nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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