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NCT Number: NCT06618625

Tube Rotation for Tube Passage Into the Oral Cavity in Nasotracheal Intubation

The purpose of the study is to investigate the effect of tube rotation on passage of the tracheal tube through the nasopharynx into the oral cavity in nasotracheal intubation.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This prospective randomized controlled study was approved by IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility of the study. Then, patients will be randomized to one of two groups; (group I: tube advancement in neutral / group II: tube advancement with the tube counter-clockwise rotated). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via a nostril approximately 3-4 cm. Next, an anesthesiologist will advance the tube, with it neutral, continuously into the oral cavity of the patients in Group I, while the anesthesiologist will advance the tube, with it rotated counter-clockwise in 90 degree, into the oral cavity of the patients in Group II. After the tube will be placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtainment of all data, investigators will analyze incidence of epistaxis and its severity between two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients requiring nasotracheal intubation for elective surgery

Exclusion criteria

  • refuse to participate in the study
  • severe deformity in nose
  • current severe epistaxis
  • limitation of neck extension

Treatment and study plan

Nasotracheal intubation

Procedure

For nasotracheal intubation, the nasal RAE tube will be inserted with it rotated by 90 degrees in counter-clockwise direction for patients in the 'Rotation' arm.

For nasotracheal intubation, the nasal RAE tube will be inserted without tube rotation for patients in the 'Neutral' arm.

Primary outcomes

  1. tube blockade

    Time frame: during tube advancement from the nasal cavity to the oral cavity

    tube blockade when an anesthesiologist is advancing the tracheal tube from the nasal cavity to the oral cavity.

Secondary outcomes

  1. epistaxis

    Time frame: during nasotracheal intubation

    epistaxis due to nasotracheal intubation

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Man Lee, M.D., Ph.D.

CONTACT

[email protected]

+82-2-870-2513

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study title

The Effect of Tube Rotation on Passage of Tracheal Tube Through Nasopharynx Into the Oral Cavity in Nasotracheal Intubation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

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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