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Clinical Trials/NCT04061629
NCT04061629CompletedNot Applicable

Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

Nationwide Children's Hospital1 site in 1 country147 target enrollmentStarted: September 18, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
147
Locations
1
Primary Endpoint
Number of participants that needed their ETT exchanged

Study Overview

Brief Summary

Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria

  • Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.

Outcomes

Primary Outcomes

Number of participants that needed their ETT exchanged

Time Frame: Immediately following intubation

Having to remove the original ETT and replacing it with a smaller or larger size due to excessive air leak or excessive pressure in the cuff.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Senthil G. Krishna

Clinical Associate Professor of Anesthesiology

Nationwide Children's Hospital

Study Sites (1)

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