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

NCT06618625 | Not Yet Recruiting

• 1 other identifier: 10-2023-61
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• tube blockade

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

  during tube advancement from the nasal cavity to the oral cavity

Secondary Outcomes (1)

• epistaxis

  during nasotracheal intubation

Study Arms (2)

Rotation

EXPERIMENTAL

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.

Procedure: nasotracheal intubation

Neutral

ACTIVE COMPARATOR

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

Procedure: nasotracheal intubation

Interventions

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.

Neutral; Rotation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients requiring nasotracheal intubation for elective surgery

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Related Publications (1)

• Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.

  PMID: 31421677 BACKGROUND

Central Study Contacts

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

CONTACT

+82-2-870-2513; jungman007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: September 23, 2024
• Primary Completion: August 22, 2025
• Study Completion: September 22, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share