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

Nationwide Children's Hospital logo

Nationwide Children's Hospital

Status

Completed

Conditions

Surgical Procedure, Unspecified

Treatments

Device: Cuffed ETT

Study type

Observational

Funder types

Other

Identifiers

NCT04061629
IRB17-00700

Details and patient eligibility

About

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.

Enrollment

147 patients

Sex

All

Ages

Under 8 years old

Volunteers

No Healthy Volunteers

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.

Trial design

147 participants in 3 patient groups

Group C
Description:
Size of the cuffed ETT based on the Cole formula = (Age/4) + 4.
Treatment:
Device: Cuffed ETT
Group D
Description:
size of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm.
Treatment:
Device: Cuffed ETT
Group K
Description:
size of the cuffed ETT based on the Khine formula = (Age/4) + 3.
Treatment:
Device: Cuffed ETT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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