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

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: Cuffed ETT

• Registration Number: NCT04061629
• Lead Sponsor: Nationwide Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants that needed their ETT exchanged	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States