Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166101
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2005-09-12
Brief Title:
NIRS in Neonatal Cardiac Surgery
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion
Status:
COMPLETED
Status Verified Date:
2012-11
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:
Due to the small size of infants and the use of bypass machines physicians have difficulty assessing whether the infants brain and body is getting enough oxygen during heart surgery This study compares continuous monitoring via the NIRS Near Infrared Spectroscopy to the traditional methods of determining oxygen saturation
Detailed Description:
One of the limiting factors in treating infants undergoing cardiac surgery is the difficulty in assessing systemic perfusion with accuracy At Childrens Healthcare of Atlanta Near-infrared Spectroscopy NIRS is available but has never been studied In patients undergoing first stage palliation Norwood for hypoplastic left heart routine management will be utilized in addition to the NIRS monitor The following will be documented pre- and post-bypass then every 4 hours for 24 hours after admission to the Cardiac Intensive Care UnitNIRS readings Lactic acid levelsmixed venous saturationshemoglobin hematocrit arterial blood gases heart rate blood pressure central venous pressure left atrium pressurecore temperature toe temperature pulse oximeter reading urine output ventilator settings inotropic levels All the data will be entered into a database and analyzed
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