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Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)

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. Identifier: NCT02160522
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Edward Ferenczy, Nationwide Children's Hospital

Brief Summary:
Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

Condition or disease Intervention/treatment
Endotracheal Tube Cuff Pressure Pediatric Emergency Device: Cuffed ETT

Detailed Description:
Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Group/Cohort Intervention/treatment
Cuffed ETT
Patients that are intubated with a cuffed endotracheal tube.
Device: Cuffed ETT
Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.

Primary Outcome Measures :
  1. Cuff pressure [ Time Frame: One time in the ED prior to discharge to the ICU ]
    One measurement of the ETT cuff pressure after intubation in the emergency department.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.

Inclusion Criteria:

  • cuffed ETT in place on arrival in the ED
  • cuffed ETT placed while in the ED

Exclusion Criteria:

  • ETT cuff electively left deflated by practitioner
  • Uncuffed ETT used

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 identifier (NCT number): NCT02160522

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Edward Ferenczy
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Principal Investigator: Edward Ferenczy, MD Nationwide Children's Hospital
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Responsible Party: Edward Ferenczy, Emergency Medicine Fellow, Nationwide Children's Hospital Identifier: NCT02160522    
Other Study ID Numbers: IRB14-00215
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Edward Ferenczy, Nationwide Children's Hospital:
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes