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Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01252173
First Posted: December 2, 2010
Last Update Posted: April 21, 2015
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.
Information provided by (Responsible Party):
Beth Israel Medical Center
  Purpose

The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED.

There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure.

This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.


Condition
Intubation, Intratracheal

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: MEASUREMENT OF ENDOTRACHEAL TUBE CUFF PRESSURE IN EMERGENCY DEPARTMENT PATIENTS

Further study details as provided by Beth Israel Medical Center:

Enrollment: 0
Study Start Date: October 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All emergency department patients, and all patients admitted from the ED
Criteria

Inclusion Criteria:

  • Patient emergently endotracheally intubated with a cuffed endotracheal tube.

Exclusion Criteria:

  • Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location.
  • Non-emergent or elective endotracheal intubation.
  Contacts and Locations
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): NCT01252173


Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Robert Hoffman, MD Beth Israel Medical Center
  More Information

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01252173     History of Changes
Other Study ID Numbers: 120-05
First Submitted: December 1, 2010
First Posted: December 2, 2010
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Beth Israel Medical Center:
endotracheal
intubation
tracheal
pressure
cufflator

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes