Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure

Not Applicable

Completed

• Conditions: ETT Size; Intracuff Pressure
• Interventions: Procedure: Surgery less than 60 minutes

• Registration Number: NCT02376101
• Lead Sponsor: Senthil G. Krishna

Brief Summary

The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-03
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients requiring intubation with an ETT for a surgical procedure.
• Children ages 4 to 8 years old.
• Surgical procedure lasting less than 60 minutes.

Exclusion Criteria

• Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
• Patients that are known or anticipated to have a difficult airway.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ETT size	Surgery less than 60 minutes	Their tracheas will be intubated with an appropriately sized ETT using the standard formula. The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer.
ETT one size smaller	Surgery less than 60 minutes	Their tracheas will be intubated with an ETT that is one size smaller (instead of a 5.0 ETT, we would use a 4.0 ETT). The cuff will be inflated to achieve a seal by the air-leak test when holding CPAP of 20 cmH2O and the intracuff pressure will be measured using a manometer.

Primary Outcome Measures

Name	Time	Method
Intracuff pressure	intraoperative	Our goal is to measure the intracuff pressure that is achieved when the airway is sealed with an ETT based on the formula (ETT=(age/4)+3) and compare it to the intracuff pressure when the airway is sealed with an ETT that is 1 size smaller (4.0 mm instead of 5.0 mm).