Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01630694
Status:
TERMINATED
Last Update Posted:
2016-01-20
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Three-dimensional Craniofacial Phenotyping of Patients With Difficult Airway
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Three -Dimensional (3-D) Craniofacial Phenotyping of Patients With Difficult Airway
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study stopped due to not meeting enrollment goal.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify differences in craniofacial morphology and tongue size between patients who have a history of difficult airway management and a control group of patients who had an uneventful airway management during induction of general anesthesia. In this study the investigators want to validate the hypothesis that there are craniofacial phenotypic differences between patients who have a history of difficult airway management and a control group of patients who have had an uneventful airway management during the induction of general anesthesia.
Detailed Description:
Difficult airway management is one of the most challenging tasks for anesthesiologists. Recent data from the American Society of Anesthesiologists (ASA) Management Closed Claims Project \[1\] show that the percentage of claims resulting from adverse respiratory events, though on the decline (42% in the 1980s to 32% in the 1990s), continue to constitute a large source of morbidity and mortality in anesthetized patients. In 2005, a closed claims analysis of trends in anesthesia-related death and brain damage between 1975 and 2000 showed that out of all respiratory events (n=503) responsible for death and brain damage, difficult endotracheal intubation (n=115), inadequate oxygenation (n=111) and inadvertent esophageal intubation (n=66) were the top three causes \[2\].
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: