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New Devices to Measure the Intracuff Pressure

NCT ID: NCT02202798

Last Updated: 2015-02-04

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

Brief Summary

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Over the past 5 years, there has been a change in clinical practice with the use of cuffed instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies have recently introduced syringe-like devices to the market which allow the measurement of the intracuff pressure. This study proposes to prospectively compare the intracuff pressure from these devices with the gold standard technique (manometer).

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Detailed Description

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Conditions

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Patients Intubated With a Cuffed Endotracheal Tube

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Syringe device

Endotracheal tube cuff pressure measured by 2 new syringe devices.

Syringe device

Intervention Type DEVICE

Interventions

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Syringe device

Intervention Type DEVICE

Other Intervention Names

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Tru-Cuff AG Cuffill

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or younger, undergoing a procedure requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria

* None
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman, Dept. of Anesthesiology & Pain Medicine

Responsibility Role SPONSOR_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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IRB13-00741

Identifier Type: -

Identifier Source: org_study_id

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