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

NCT04441970 | Unknown

• 1 other identifier: 4-2020-0442
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Neutral position

ACTIVE COMPARATOR

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

Head extension position

EXPERIMENTAL

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

Procedure: Head extension position

Head flexion position

EXPERIMENTAL

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

Procedure: Head flexion position

Head rotation position

EXPERIMENTAL

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

Procedure: Head rotation position

Interventions

Neutral position PROCEDURE

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

Neutral position

Head extension position PROCEDURE

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

Head extension position

Head flexion position PROCEDURE

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

Head flexion position

Head rotation position PROCEDURE

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

Head rotation position

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Hyun Joo Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Joo Kim

CONTACT

82-2-2224-1389; jjollong@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: June 24, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)