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

NCT03740620 | Completed

• 1 other identifier: 30-2018-76
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis; Intubation Complication

Keywords

epistaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• incidence and severity of epistaxis

  right after completion of the intubation

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

conventional group

ACTIVE COMPARATOR

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

Interventions

Bevel facing the cephalad direction of the patient PROCEDURE

The bevel of the nasotracheal tube facing cephalad direction of the patient

intervention group

Bevel facing leftward of the patient PROCEDURE

The bevel of the nasotracheal tube facing the left side of the patient

conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 07061, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33009189 DERIVED

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: January 14, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

KR (1)