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Cuff Pressure in LMS

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ClinicalTrials.gov Identifier: NCT03929848
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.

Condition or disease Intervention/treatment
Laryngomicrosurgery Procedure: Cuff pressure

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.


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Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 30, 2020

Group/Cohort Intervention/treatment
female
female patient who is scheduled for laryngomicrosurgery
Procedure: Cuff pressure
observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery

male
male patient who is scheduled for laryngomicrosurgery
Procedure: Cuff pressure
observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery




Primary Outcome Measures :
  1. Cuff pressure [ Time Frame: intraoperative ]
    the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patient who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929848


Contacts
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Contact: Jung-Man Lee, M.D.,PhD. +82-2-870-2513 jungman007@gmail.com

Locations
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Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of, 07061
Contact: Jung-Man Lee, M.D.,Ph.D.    82-10-9553-0916    jungman007@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jung-Man Lee, M.D.,PhD SMG-SNU Boramae Medical Center

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929848     History of Changes
Other Study ID Numbers: 20-2018-106
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seoul National University Hospital:
cuff pressure, laryngomicrosurgery