NCT03929848

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

April 25, 2019

Last Update Submit

April 29, 2019

Conditions

Laryngomicrosurgery

Keywords

cuff pressure, laryngomicrosurgery

Outcome Measures

Primary Outcomes (2)

  • Cuff pressure

    the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery

    intraoperative

  • post operative complication

    any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea

    from end of surgery to 1-2 weeks after surgery

Study Arms (2)

female

female patient who is scheduled for laryngomicrosurgery

Procedure: Cuff pressure

male

male patient who is scheduled for laryngomicrosurgery

Procedure: Cuff pressure

Interventions

Cuff pressurePROCEDURE

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

femalemale

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

You may qualify if:

  • patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Study Officials

  • Jung-Man Lee, M.D.,PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+82-2-870-2513jungman007@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 29, 2019

Study Start

April 30, 2019

Primary Completion

March 31, 2020

Study Completion

April 30, 2020

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

KR(1)