- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929848
Cuff Pressure in LMS
Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -
Study Overview
Detailed Description
It has been well known that cuff pressure should be adequately limited to prevent ischemic injury of tracheal mucosa, which is about 20-30 mmHg. However, higher cuff pressure that 20-30 mmHg might be required to prevent gas leakage during general anesthesia for laryngomicrosurgery.
The hypothesis of this study is that the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery, and there will be no damage from the required cuff pressure because of short time of surgery.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jung-Man Lee, M.D.,PhD.
- Phone Number: +82-2-870-2513
- Email: jungman007@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 07061
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
Contact:
- Jung-Man Lee, M.D.,Ph.D.
- Phone Number: 82-10-9553-0916
- Email: jungman007@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Exclusion Criteria:
- Who doesn't agree to enroll
- do not use a reinforced tracheal tube of internal diameter of 5.5 mm for male patient
- do not use a reinforced tracheal tube of internal diameter of 5.0 mm for female patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
female
female patient who is scheduled for laryngomicrosurgery
|
observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery
|
male
male patient who is scheduled for laryngomicrosurgery
|
observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cuff pressure
Time Frame: intraoperative
|
the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery
|
intraoperative
|
post operative complication
Time Frame: from end of surgery to 1-2 weeks after surgery
|
any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea
|
from end of surgery to 1-2 weeks after surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-2018-106
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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