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CompletedNCT02202798Updated Feb 4, 2015

New Devices to Measure the Intracuff Pressure

An observational study in Patients Intubated With a Cuffed Endotracheal Tube, sponsored by Joseph D. Tobias. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2015-02-04.

Sponsored by Joseph D. Tobias · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
Up to 18 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Patients Intubated With a Cuffed Endotracheal Tube
03

In context

Lead sponsor

Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients that are being intubated with a cuffed endotracheal tube prior to surgery.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • Syringe device

    Endotracheal tube cuff pressure measured by 2 new syringe devices.

    Device: Syringe device

Interventions

  • DeviceSyringe device

    Also known as: Tru-Cuff, AG Cuffill

06

What researchers measure

Primary outcomes

  1. Cuff pressure

    Time frame: One time in the OR prior to the start of surgery

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02202798
Lead sponsor
Joseph D. Tobias
Responsible party
Joseph D. Tobias (Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Jul 29, 2014
Start date
Nov 2013
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Feb 4, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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