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

NCT04061629 | Completed

• 1 other identifier: IRB17-00700
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group C

Size of the cuffed ETT based on the Cole formula = (Age/4) + 4.

Device: Cuffed ETT

Group D

size of the cuffed ETT based on the Duracher formula = (Age/4) + 3 + 0.5 mm.

Device: Cuffed ETT

Group K

size of the cuffed ETT based on the Khine formula = (Age/4) + 3.

Device: Cuffed ETT

Interventions

Cuffed ETT DEVICE

Cuffed endotracheal tube.

Group C; Group D; Group K

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring an endotracheal tube for surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: September 18, 2017
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)