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Cuff Pressure in LMS

  • Clinicaltrials.gov identifier

    NCT03929848

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    May 1, 2019

Study Description

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:Laryngomicrosurgery
  • Intervention/Treatment: Procedure: Cuff pressure
  • Phase: N/A

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 Design

  • 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 2019
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: April 2020

Groups and Cohorts

Groups/Cohorts 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

Outcome Measures

  • 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • 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

Contacts and Locations

Contacts

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

Locations

Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul

Sponsors and Collaborators

Seoul National University Hospital

SMG-SNU Boramae Medical Center

Investigators

Principal Investigator: Jung-Man Lee, M.D.,PhD SMG-SNU Boramae Medical Center

More Information

  • 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
  • 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