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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02376101
Enrollment
100
Registered
2015-03-03
Start date
2014-10-31
Completion date
2016-07-31
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ETT Size, Intracuff Pressure

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.

Interventions

PROCEDURESurgery less than 60 minutes

Sponsors

Senthil G. Krishna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intracuff pressureintraoperativeOur 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026