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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03740620
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Epistaxis; Intubation Complication	Procedure: Bevel facing the cephalad direction of the patient; Procedure: Bevel facing leftward of the patient	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 14, 2019
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intervention group In the intervention group, a nasotracheal tube is inserted into the nostril with the bevel of the tube facing the cephalad direction of the patient.	Procedure: Bevel facing the cephalad direction of the patient; The bevel of the nasotracheal tube facing cephalad direction of the patient
Active Comparator: conventional group In the conventional group, a nasotracheal tube is inserted in a usual way, i.e., with the bevel of the tube facing the left side of the patient.	Procedure: Bevel facing leftward of the patient; The bevel of the nasotracheal tube facing the left side of the patient

Outcome Measures

Primary Outcome Measures

1. incidence of the tube in lower pathway [right after completion of the intubation]

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

Secondary Outcome Measures

1. intubation time [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]

   time to complete endotracheal intubation

2. incidence and severity of epistaxis [right after completion of the intubation]

   incidence and severity of epistaxis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tae Kyong Kim, Clinical Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03740620
• Other Study ID Numbers: 30-2018-76
• First Posted: Nov 14, 2018
• Last Update Posted: Oct 4, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tae Kyong Kim, Clinical Assistant Professor, Seoul National University Hospital: epistaxis
• Additional relevant MeSH terms: Epistaxis

Study Results

No Results Posted as of Oct 4, 2021