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New Devices to Measure the Intracuff Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202798
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief 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).

Condition or disease Intervention/treatment
Patients Intubated With a Cuffed Endotracheal Tube Device: Syringe device

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Group/Cohort Intervention/treatment
Syringe device
Endotracheal tube cuff pressure measured by 2 new syringe devices.
Device: Syringe device
Other Names:
  • Tru-Cuff
  • AG Cuffill




Primary Outcome Measures :
  1. Cuff pressure [ Time Frame: One time in the OR prior to the start of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202798


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02202798    
Other Study ID Numbers: IRB13-00741
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015