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

Not Applicable

• Conditions: Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia
• Interventions: Procedure: Head extension position; Procedure: Head flexion position; Procedure: Head rotation position; Procedure: Neutral position

• Registration Number: NCT04441970
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Study Start: 2020-06-24
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Head extension position	Head extension position	After changing the posture of the head and neck into head extension, cuff pressure will be recorded.
Head flexion position	Head flexion position	After changing the posture of the head and neck into head flexion, cuff pressure will be recorded.
Head rotation position	Head rotation position	After changing the posture of the head and neck into head rotation, cuff pressure will be recorded.
Neutral position	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.

Primary Outcome Measures

Name	Time	Method
cuff pressure of the nasotracheal tube	for 10 minutes after intubating the nasotracheal tube. At Day 0.	Cuff pressure will be measured in the various head and neck positions.

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of