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

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.

Study Overview

• 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
• Intervention / Treatment: Procedure: Neutral position; Procedure: Head extension position; Procedure: Head flexion position; Procedure: Head rotation position

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyun Joo Kim; Phone Number: 82-2-2224-1389; Email: jjollong@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei Severance Hospital
    • Contact: Hyun Joo Kim; Phone Number: 82-2-2224-1389; Email: jjollong@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The cuff pressure will be recorded at the neutral head 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; The cuff pressure will be recorded at the 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; The cuff pressure will be recorded at the 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; The cuff pressure will be recorded at the head rotation position.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Hyun Joo Kim, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 4-2020-0442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No