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OpenTrials
Completed

NCT Number: NCT03938493

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitoring of the endotracheal tube cuff

Other

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.

Primary outcomes

  1. Changes of cuff pressure during anesthesia

    Time frame: participants 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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