Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT01651260
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of an Endotracheal Tube Securement Device
Sponsor:
Hollister Incorporated
Organization:
Study Overview
Official Title:
Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.
Detailed Description:
This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.
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?: