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

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 Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Device: Cuffed ETT

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children requiring an endotracheal tube for surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that needed their ETT exchanged	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.	Immediately following intubation

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): July 18, 2019
• Study Completion (ACTUAL): July 18, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (ACTUAL): August 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB17-00700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No