Cuff Pressure in LMS

Laryngomicrosurgery Clinical Trial

Official title:

Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03929848
• Other study ID #: 20-2018-106
• Status: Not yet recruiting
• Start date: April 30, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: Jung-Man Lee, M.D.,PhD.
• Phone: +82-2-870-2513
• Email: jungman007[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: April 30, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngomicrosurgery

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cuff pressure	the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery	intraoperative
Primary	post operative complication	any postoperative symptoms associated with cuff pressure such as hoarsness, dyspnea	from end of surgery to 1-2 weeks after surgery