Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759222
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2021-02-10
Brief Title:
Microvascular Reactivity in Cardiac Surgery
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
Microvascular Reactivity as a Predictor of Major Adverse Events in Patients With On-pump Cardiac Surgery A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Microcirculatory disturbance occurs most seriously during cardiopulmonary bypass CPB in cardiac surgery If microvascular reactivity compensates for microcirculatory disturbance during CPB tissue hypoxemia may be minimized On the other hand tissue hypoxemia may develop and lead to poor clinical outcomes The primary aim of this study was to assess whether microvascular reactivity during CPB can predict major adverse events MAE within 30 days after cardiac surgery
This prospective observational single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery The vascular occlusion test VOT with near-infrared spectroscopy was performed five times for each patient before the induction of general anesthesia baseline T0 30 min after the induction of general anesthesia T1 30 min after applying CPB T2 10 min after injection of protamine T3 and after sternal closure T4 Sequential Organ Failure Assessment SOFA and Acute Physiologic and Chronic Health Evaluation APACHE II scores and the length of ventilator care intensive care unit stay and hospital stay were recorded Postoperative MAE within 30 days after surgery was also recorded
This prospective observational single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery The vascular occlusion test VOT with near-infrared spectroscopy was performed five times for each patient before the induction of general anesthesia baseline T0 30 min after the induction of general anesthesia T1 30 min after applying CPB T2 10 min after injection of protamine T3 and after sternal closure T4 Sequential Organ Failure Assessment SOFA and Acute Physiologic and Chronic Health Evaluation APACHE II scores and the length of ventilator care intensive care unit stay and hospital stay were recorded Postoperative MAE within 30 days after surgery was also recorded
Detailed Description:
The VOT was performed five times in each patient before the induction of general anesthesia baseline T0 30 min after the induction of general anesthesia T1 30 min after applying CPB T2 10 min after injection of protamine T3 and after sternal closure T4 Before induction of anesthesia an NIRS sensor INVOS 5100C CerebralSomatic Oximeter Medtronic Minneapolis MN USA was placed on the thenar eminence and an automated tourniquet ATS 3000 Automatic Tourniquet System Zimmer Inc Warsaw IL USA was placed around the upper arm The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured When the baseline tissue oxygen saturation StO2 was stabilized the automatic tourniquet was inflated to 50 mmHg over the patients baseline systolic blood pressure and maintained for 5 min After the 5-min ischemic period the tourniquet rapidly deflated to 0 mmHg StO2 data were continuously recorded during the VOT procedure Baseline StO2 minimum StO2 during the 5-min inflation of the tourniquet and maximum StO2 during deflation of the tourniquet were obtained The occlusion slope and recovery slope were calculated based on the measured StO2 data The occlusion slope which is related to oxygen extraction was defined as the slope of the StO2 descent to the lowest value The recovery slope which is related to microvascular reactivity was calculated from the deflation of the tourniquet until the recovery of StO2 to the highest value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None