Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256724
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2005-11-18
Brief Title:
Efficacy Study of a Facemask Device to Treat Hypotension
Sponsor:
Advanced Circulatory Systems
Organization:
Advanced Circulatory Systems
Study Overview
Official Title:
Evaluation of an Inspiratory Impedance Threshold Device ITD in the Emergency Department for the Treatment of Hypotension
Status:
COMPLETED
Status Verified Date:
2013-07
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:
The purpose of this study is to determine if the impedance threshold device ITD attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia The cause of hypovolemia could be blood loss sepsis or dehydration
Detailed Description:
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of 95mmHg The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use Based upon pre-clinical studies as well as clinical studies performed to date we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD Multiple additional clinical parameters will also be compared between the two groups of patients
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Contract W81XWH-04-C-0022 | None | None | None |