The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube

Intubation Complication Clinical Trial

Official title:

The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740620
• Other study ID #: 30-2018-76
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

Description:

Primary outcome

• incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) Secondary outcome

• intubation time

• incidence of epistaxis

• severity of bleeding

• Resistance during Insertion of the tracheal tube

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a patient who will take operation which needs nasotracheal intubation under general anesthesia

Exclusion Criteria:

• a patient who didn't agree to participate in this study

• a patient who has a deformity of the nose

• a patient who has a history of severe epistaxis

• a patient who has coagulation problem

• a patient who has a history of the fracture or surgery of the skull base

Related Conditions & MeSH terms

• Epistaxis
• Intubation Complication

Intervention

Procedure:
• Bevel facing the cephalad direction of the patient
The bevel of the nasotracheal tube facing cephalad direction of the patient
• Bevel facing leftward of the patient
The bevel of the nasotracheal tube facing the left side of the patient

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of the tube in lower pathway	incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril)	right after completion of the intubation
Secondary	intubation time	time to complete endotracheal intubation	from the start of the intubation to the completion of the intubation, which is confirmed by the appearance of end-tidal CO2 curve, up to 60 seconds
Secondary	incidence and severity of epistaxis	incidence and severity of epistaxis	right after completion of the intubation