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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03938506

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 9, 2019

Study Description

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.

  • Condition or Disease:Intubation, Intratracheal
  • Intervention/Treatment: Other: cuff pressure of the endotracheal tube
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 208 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
  • Estimated Study Start Date: November 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: June 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: intubation using the endotracheal tube size of 6.0 or 8.0
Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
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.
Outcome Measures
  • Primary Outcome Measures: 1. The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range. [ Time Frame: 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.
Eligibility Criteria
  • Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Criteria

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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Yonsei University

More Information
  • Responsible Party: Yonsei University
  • ClinicalTrials.gov Identifier: NCT03938506 History of Changes
  • Other Study ID Numbers: 4-2019-0104
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 9, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Yonsei University: endotracheal tube cuff Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0