Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01252173
First received: December 1, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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:

Estimated Enrollment: 80
Study Start Date: October 2005
Estimated Study Completion Date: July 2006
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252173

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

No publications provided

Responsible Party: Robert Hoffman, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01252173     History of Changes
Other Study ID Numbers: 120-05
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014