CClinicalTrials.gg
Status unknownNCT03938506Updated May 9, 2019

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

An observational study in Intubation, Intratracheal, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
208
Ages
20 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Intubation, Intratracheal

Keywords

  • Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
  • endotracheal tube cuff
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. Patients under 20 years old
    1. Patients receiving emergency surgery
    1. Patients with tracheostomy tubes
    1. Pregnant women
    1. Patients who can not read the consent form or are not fluent in Korean
    1. Patients who refused the clinical trial
    1. Patient with endotracheal mass in the trachea where the cuff is located
    1. Tracheal deviation is observed in the neck due to tumor in the neck
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
208 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Othercuff 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will followed until the completion of the anesthetic induction (less than 15 minutes).

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03938506
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Nov 2019 (estimated)
Primary completion
May 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
May 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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