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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01252173
Other study ID # 120-05
Secondary ID
Status Withdrawn
Phase N/A
First received December 1, 2010
Last updated April 20, 2015
Start date October 2005
Est. completion date September 2006

Study information

Verified date April 2015
Source Beth Israel Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Medical Center
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