Cuff Pressure in LMS

• Conditions: Laryngomicrosurgery
• Interventions: Procedure: Cuff pressure

• Registration Number: NCT03929848
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Last Update Submitted: 2019-04-29
• Study Start: 2019-04-30
• Last Update Posted: 2019-05-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
male	Cuff pressure	male patient who is scheduled for laryngomicrosurgery
female	Cuff pressure	female patient who is scheduled for laryngomicrosurgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

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