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

Senthil G. Krishna

Status: Completed

Conditions: Intracuff Pressure; ETT Size

Treatments: Procedure: Surgery less than 60 minutes

Study type: Interventional

Funder types: Other

Identifiers

NCT02376101

IRB14-00521

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Standard ETT size

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgery less than 60 minutes

ETT one size smaller

Experimental group

Description:

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.

Treatment:

Procedure: Surgery less than 60 minutes