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

NCT ID: NCT04061629

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-18

Study Completion Date

2019-07-18

Brief Summary

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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

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Conditions

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Surgical Procedure, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group C

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

Cuffed ETT

Intervention Type DEVICE

Cuffed endotracheal tube.

Group D

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

Cuffed ETT

Intervention Type DEVICE

Cuffed endotracheal tube.

Group K

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

Cuffed ETT

Intervention Type DEVICE

Cuffed endotracheal tube.

Interventions

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Cuffed ETT

Cuffed endotracheal tube.

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Senthil G. Krishna

Clinical Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-00700

Identifier Type: -

Identifier Source: org_study_id

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