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

NCT ID: NCT02376101

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard ETT size

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.

Group Type: ACTIVE_COMPARATOR

Surgery less than 60 minutes

Intervention Type: PROCEDURE

ETT one size smaller

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.

Group Type: EXPERIMENTAL

Surgery less than 60 minutes

Intervention Type: PROCEDURE

Interventions

Surgery less than 60 minutes

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senthil G. Krishna

OTHER

Sponsor Role: lead

Responsible Party

Senthil G. Krishna

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

IRB14-00521

Identifier Type: -

Identifier Source: org_study_id