The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes

Intubation, Intratracheal Clinical Trial

Official title:

The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03938506
• Other study ID #: 4-2019-0104
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: June 2020

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• 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 common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 1. Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0

Exclusion Criteria:

• 1. Patients under 20 years old

• 2. Patients receiving emergency surgery

• 3. Patients with tracheostomy tubes

• 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

• 7. Patient with endotracheal mass in the trachea where the cuff is located

• 8. Tracheal deviation is observed in the neck due to tumor in the neck

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Other:
• cuff pressure of the endotracheal tube
The endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer.

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	The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range.	the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.	participants will followed until the completion of the anesthetic induction (less than 15 minutes).