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

• Conditions: Intubation, Intratracheal
• Interventions: Other: cuff pressure of the endotracheal tube

• Registration Number: NCT03938506
• Lead Sponsor: Yonsei University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09
• Study Start: 2019-11
• Primary Completion: 2020-05
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intubation using the endotracheal tube size of 6.0 or 8.0	cuff pressure of the endotracheal tube	Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of