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

September 22, 2020 updated by: Yonsei University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyun Joo Kim, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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