Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 2:51 AM
Study NCT ID:
NCT01001533
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2009-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
A Pilot Study to Assess the Ability of Non-invasive Bio-impedance Cardiac Monitoring to Detect and Trend Hemodynamic Variables During Dexmedetomidine (DEX) Sedation in Children for Radiology Procedures
Status:
COMPLETED
Status Verified Date:
2011-06
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:
DEX-CO
Brief Summary:
The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.
Detailed Description:
None
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?: