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NCT Number: NCT03740620

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

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.

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Key information

Conditions

Epistaxis Hemorrhage Intubation Complication Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 07061, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevel facing the cephalad direction of the patient

Procedure

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

Bevel facing leftward of the patient

Procedure

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

Primary outcomes

  1. incidence of the tube in lower pathway

    Time frame: 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 outcomes

  1. intubation time

    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

    time to complete endotracheal intubation

  2. incidence and severity of epistaxis

    Time frame: right after completion of the intubation

    incidence and severity of epistaxis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2018
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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