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

NCT02376101 | Completed

• 1 other identifier: IRB14-00521
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracuff Pressure; ETT Size

Outcome Measures

Primary Outcomes (1)

• Intracuff pressure

  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).

  intraoperative

Study Arms (2)

Standard ETT size

ACTIVE COMPARATOR

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.

Procedure: Surgery less than 60 minutes

ETT one size smaller

EXPERIMENTAL

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.

Procedure: Surgery less than 60 minutes

Interventions

Surgery less than 60 minutes PROCEDURE

ETT one size smaller; Standard ETT size

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Senthil G. Krishna: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-08