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CompletedNCT03938493Updated Jun 1, 2021

Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia

An observational study in Intubation, Intratracheal, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
201
Ages
20 Years and older
Sex
All
01

Study summary

Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.

02

Conditions studied

  • Intubation, Intratracheal

Keywords

  • Adults who require endotracheal intubation for head and neck surgery under general anesthesia
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Inclusion criteria

    1. Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

    1. Patients under 20 years old
    1. Patients who should undergo tracheostomy
    1. Patients who need to use an endotracheal tube without a cuff
    1. Pregnant women
    1. Patients who can not read the consent form or are not fluent in Korean
    1. Patients who refused the clinical trial
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
201 participants (actual)
Patient registry
No

Groups and cohorts

  • endotracheal intubation under general anesthesia

    Adults who require endotracheal intubation for head and neck surgery under general anesthesia

    Other: monitoring of the endotracheal tube cuff

Interventions

  • Othermonitoring of the endotracheal tube cuff

    We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.

06

What researchers measure

Primary outcomes

  1. Changes of cuff pressure during anesthesia

    The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.

    Time frame: participants will followed until post-operative 1 day.

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03938493
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Apr 28, 2020
Primary completion
Nov 4, 2020
Completion
Nov 4, 2020
Last update
Jun 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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