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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 18, 2019

Interventions

  • Device: Cuffed ETT
    • Cuffed endotracheal tube.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nationwide Children’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Senthil G. Krishna, Clinical Associate Professor of Anesthesiology – Nationwide Children’s Hospital

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