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OpenTrials
Completed

NCT Number: NCT02376101

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

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.

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Key information

Conditions

Intracuff Pressure ETT Size

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery less than 60 minutes

Procedure

Primary outcomes

  1. Intracuff pressure

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Senthil G. Krishna

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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