LaryngomicrosurgeryNCT03929848
Cuff Pressure in LMS
An observational study of Laryngomicrosurgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngomicrosurgery
- What is being tested?
- Cuff pressure
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Who may be able to join
- patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
Jung-Man Lee, M.D.,Ph.D., 82-10-9553-0916, jungman007@gmail.com
About this study
Official title: Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -
The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.
Read the 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.
- Conditions
- Laryngomicrosurgery
- Being tested
- Cuff pressure
- Keywords
- cuff pressure, laryngomicrosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuff pressureProcedure or surgery
observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery
| Study group | Role | What they receive |
|---|---|---|
| female | female patient who is scheduled for laryngomicrosurgery Receives: Procedure: Cuff pressure | |
| male | male patient who is scheduled for laryngomicrosurgery Receives: Procedure: Cuff pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff pressure
the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery
Measured: intraoperative
post operative complication
any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea
Measured: from end of surgery to 1-2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start30 Apr 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngomicrosurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929848
- Sponsor's protocol ID
- 20-2018-106
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -
- ClinicalTrials.gov ID
- NCT03929848
- Acronym / sponsor ID
- 20-2018-106
- Conditions
- Laryngomicrosurgery
- Keywords
- cuff pressure, laryngomicrosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 30 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female | – | Procedure: Cuff pressurefemale patient who is scheduled for laryngomicrosurgery |
| male | – | Procedure: Cuff pressuremale patient who is scheduled for laryngomicrosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Key inclusion criteria (1 listed)
- patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuff pressureobserve and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery | Procedure or surgery | female, male |
Primary outcome
Cuff pressure
Time frame: intraoperative
the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Man Lee, M.D.,PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngomicrosurgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Man Lee, M.D.,PhD. (+82-2-870-2513, jungman007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cuff pressure (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.