Cuff Pressure in LMS

NCT ID: NCT03929848

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Laryngomicrosurgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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female

female patient who is scheduled for laryngomicrosurgery

Cuff pressure

Intervention Type PROCEDURE

observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery

male

male patient who is scheduled for laryngomicrosurgery

Cuff pressure

Intervention Type PROCEDURE

observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery

Interventions

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Cuff pressure

observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jung-Man Lee, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jung-Man Lee, M.D.,PhD.

Role: CONTACT

+82-2-870-2513

Facility Contacts

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Jung-Man Lee, M.D.,Ph.D.

Role: primary

82-10-9553-0916

Other Identifiers

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20-2018-106

Identifier Type: -

Identifier Source: org_study_id

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