Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03938493
Enrollment
201
Registered
2019-05-06
Start date
2020-04-28
Completion date
2020-11-04
Last updated
2021-06-01

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

Conditions

Intubation, Intratracheal

Keywords

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

Brief 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.

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

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

Exclusion criteria

* 1\. Patients under 20 years old * 2\. Patients who should undergo tracheostomy * 3\. Patients who need to use an endotracheal tube without a cuff * 4\. Pregnant women * 5\. Patients who can not read the consent form or are not fluent in Korean * 6\. Patients who refused the clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Changes of cuff pressure during anesthesiaparticipants will followed until post-operative 1 day.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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026