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

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ClinicalTrials.gov Identifier: NCT02376101
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Senthil G. Krishna, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Intracuff Pressure ETT Size Procedure: Surgery less than 60 minutes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
Study Start Date : October 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Surgery less than 60 minutes
Experimental: 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.
Procedure: Surgery less than 60 minutes



Primary Outcome Measures :
  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).



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Senthil G. Krishna, Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02376101    
Other Study ID Numbers: IRB14-00521
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: August 2016