search
Back to results

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

Primary Purpose

Epistaxis, Intubation Complication

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevel facing the cephalad direction of the patient
Bevel facing leftward of the patient
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epistaxis focused on measuring epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intervention group

conventional group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

intubation time
time to complete endotracheal intubation
incidence and severity of epistaxis
incidence and severity of epistaxis

Full Information

First Posted
November 2, 2018
Last Updated
October 1, 2021
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03740620
Brief Title
The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Intubation Complication
Keywords
epistaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bevel facing the cephalad direction of the patient
Intervention Description
The bevel of the nasotracheal tube facing cephalad direction of the patient
Intervention Type
Procedure
Intervention Name(s)
Bevel facing leftward of the patient
Intervention Description
The bevel of the nasotracheal tube facing the left side of the patient
Primary Outcome Measure Information:
Title
incidence of the tube in lower pathway
Description
incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril)
Time Frame
right after completion of the intubation
Secondary Outcome Measure Information:
Title
intubation time
Description
time to complete endotracheal intubation
Time Frame
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
Title
incidence and severity of epistaxis
Description
incidence and severity of epistaxis
Time Frame
right after completion of the intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33009189
Citation
Won D, Kim H, Chang JE, Lee JM, Min SW, Jung J, Yang HJ, Hwang JY, Kim TK. Effect of bevel direction on the tracheal tube pathway during nasotracheal intubation: A randomised trial. Eur J Anaesthesiol. 2021 Feb 1;38(2):157-163. doi: 10.1097/EJA.0000000000001347.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs