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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04441970
Enrollment
50
Registered
2020-06-22
Start date
2020-06-24
Completion date
2021-03-31
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

PROCEDUREHead extension position

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

PROCEDUREHead flexion position

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

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cuff pressure of the nasotracheal tubefor 10 minutes after intubating the nasotracheal tube. At Day 0.Cuff pressure will be measured in the various head and neck positions.

Countries

South Korea

Contacts

Primary ContactHyun Joo Kim
jjollong@yuhs.ac82-2-2224-1389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026