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Status unknownNCT04441970Updated Sep 23, 2020

The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube

An interventional study of Neutral position and Head extension position in Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study summary

Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. After the nasotracheal tube is placed in the patient's trachea, the process of inflating the cuff at the end of the tube with air is required. If the cuff is inflated with excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it is highly likely to cause ischemia. In addition, it was found that the pressure in the excessively inflated cuff was associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the patient's head and neck posture. The pressure changes in the cuff may vary depending on the material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head and neck posture on the pressure in the cuff of nasotracheal tube.

02

Conditions studied

  • Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients over 20 years of age
  • patients who require intubation of the nasotracheal tube to undergo oral and maxillofacial surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Patients whose neck cannot be rotated due to cervical diseases, cervical fractures, and previous cervical surgery
  • Patients undergoing emergency surgery
  • Pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Neutral position

    General anesthesia will be induced and nasotracheal tube will be placed through the patient's nose. After 30 seconds, the cuff pressure will be measured using a cuff manometer. Inspiratory tidal volume, expiratory tidal volume, peak inspiratory pressure, and end-tidal carbon dioxide waveform will be recorded three times according to breathing. Whether ventilation is not adequate and air is leaking will be recorded.

    Procedure: Neutral position

  • Experimental
    Head extension position

    After changing the posture of the head and neck into head extension, cuff pressure will be recorded.

    Procedure: Head extension position

  • Experimental
    Head flexion position

    After changing the posture of the head and neck into head flexion, cuff pressure will be recorded.

    Procedure: Head flexion position

  • Experimental
    Head rotation position

    After changing the posture of the head and neck into head rotation, cuff pressure will be recorded.

    Procedure: Head rotation position

Interventions

  • ProcedureNeutral position

    The cuff pressure will be recorded at the neutral head position.

  • ProcedureHead extension position

    The cuff pressure will be recorded at the head extension position.

  • ProcedureHead flexion position

    The cuff pressure will be recorded at the head flexion position.

  • ProcedureHead rotation position

    The cuff pressure will be recorded at the head rotation position.

06

What researchers measure

Primary outcomes

  1. cuff pressure of the nasotracheal tube

    Cuff pressure will be measured in the various head and neck positions.

    Time frame: for 10 minutes after intubating the nasotracheal tube. At Day 0.

07

Study locations

1 of 1 sites recruiting
  • Yonsei Severance Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04441970
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 22, 2020
Start date
Jun 24, 2020
Primary completion
Dec 2020 (estimated)
Completion
Mar 2021 (estimated)
Last update
Sep 23, 2020

Study contacts

Hyun Joo Kim
Contact
jjollong@yuhs.ac
82-2-2224-1389
Hyun Joo Kim
principal investigator · Severance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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