Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03938493
Other study ID # 4-2019-0100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date November 4, 2020

Study information

Verified date May 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date November 4, 2020
Est. primary completion date November 4, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
monitoring 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.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. participants will followed until post-operative 1 day.
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT03301324 - Intubation Assist Clinical Study N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Not yet recruiting NCT04116333 - Effect of Using Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions in a Manikin N/A
Recruiting NCT02001285 - Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation N/A
Completed NCT02034643 - Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure N/A
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01227486 - Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient N/A
Withdrawn NCT01252173 - Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients N/A
Completed NCT04591769 - Tracheal Tube Cuff Shape and Pressure N/A
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A
Recruiting NCT03716713 - CeraShield™ Endotracheal Tube Feasibility Study N/A
Not yet recruiting NCT03938506 - The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
Not yet recruiting NCT01974505 - Learning Curve of Optiscope by Anesthesia Providers N/A
Completed NCT06107998 - Comparison of Different Methods for Determining Endotracheal Cuff Pressure N/A
Completed NCT02822846 - Evaluation of the Ability to Diagnose the Position of the Intubation Probe Thanks to Lung Ultrasonography
Completed NCT03116373 - Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization N/A
Completed NCT02423317 - Comparison of Miller's Blade and Airtraq Laryngoscope in Children N/A
Not yet recruiting NCT04872881 - Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy Phase 4
Completed NCT04863846 - Evidence-based Algorithm for the Expected Difficult Intubation