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

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Yonsei University

Status

Unknown

Conditions

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

Treatments

Procedure: Head extension position
Procedure: Head rotation position
Procedure: Neutral position
Procedure: Head flexion position

Study type

Interventional

Funder types

Other

Identifiers

NCT04441970
4-2020-0442

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

50 participants in 4 patient groups

Neutral position
Active Comparator group
Description:
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.
Treatment:
Procedure: Neutral position
Head extension position
Experimental group
Description:
After changing the posture of the head and neck into head extension, cuff pressure will be recorded.
Treatment:
Procedure: Head extension position
Head flexion position
Experimental group
Description:
After changing the posture of the head and neck into head flexion, cuff pressure will be recorded.
Treatment:
Procedure: Head flexion position
Head rotation position
Experimental group
Description:
After changing the posture of the head and neck into head rotation, cuff pressure will be recorded.
Treatment:
Procedure: Head rotation position

Trial contacts and locations

1

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Central trial contact

Hyun Joo Kim

Data sourced from clinicaltrials.gov

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