Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839990
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-04-21
Brief Title:
Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study Overview
Official Title:
Biomechanical and Elastic Properties of the Ascending Wall of the Human Aorta in Aneurysm
Status:
COMPLETED
Status Verified Date:
2023-10
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 aim of the study is to analyze the efficacy of the surgical tretment in patients with ascending aortic aneurysm and dilatation And to assess rate of negative clinical scenarios in non-oparated patients with ascending aortic dilatation
Detailed Description:
Description of the procedures
All surgical procedures will be performed via median sternotomy During the aortic arch anastomosis continuous unilateral SACP using innominate artery will be employed Unilateral SACP may be converted to bilateral ACP at the surgeons discretion if adequate cerebral flows are not achieved or if there are concerns with cerebral oximetry measurements
Once on CPB the patient will be cooled to a nasopharyngeal NP temperature of 28-30 C Rectal temperature with be monitored as an additional temperature sites Unilateral SACP will only be initiated once the target temperature has been reached SACP via the innominate artery will be commenced with target flows of 8-10 mlkgmin and perfusion pressure of 60-80 mmHg Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy NIRS
After completion of the aortic hemiarch replacement CPB will be resumed and the patient re-warmed to 36 C prior to coming off CPB with a 1 C temperature difference between temperature monitoring sites NP and rectal
Intraoperative information will be collected from the anesthetic record surgical notes and perfusion records Intraoperative data collection will include total operative time CPB time cross-clamp time hypothermic cardiac arrest time uSACP time lowest nasopharyngeal and rectal temperature arterial pressure in both radial arteries perfusion rate and perfusion pressure during both of CPB and unilateral SACP lowest hemoglobin concentration gL and hematocrit acid-base indices intraoperative red blood cell transfusion units highest doseagent used for intraoperative inotrope or vasopressor support Also during the surgery will be performed NIRS and BIS-monitoring
Postoperative data will include valuation of following indicators mortality hospital mortality and death from any cause neurological injury TIA stroke delirium MRI and CT-scan only in event of postoperative stroke acute kidney injury creatinine level prior and 1 2 4 postoperative day POD urine output-up to 24-48 h renal replacement therapy dialysis time of mechanical ventilation re-exploration for bleeding tamponade or other reasons postoperative transfusion packed red blood cells platelets fresh frozen platelets cryoprecipitate postoperative myocardial infarction electrocardiogram and troponins inotropic support during 24-48 h agent and dose VIS length of stay intensive care unit and total hospital days
In non-operted grop of patients annually echo cardiography CT scans will be performed
Aortic imaging All measurements will be taken using electrocardiography-gated computed tomographic angiography Analysis was performed using 64-slice scanner Discovery NM-CT 570c GE Healthcare Milwaukee WI USA with spatial resolution of the angiographic phase ranging from 06 to 125 mm Adopted computed tomographic protocol included unenhanced arterial and delayed data acquisition The arterial phase will be acquired after intravenous injection of 80-100 mL of nonionic iodinated contrast at 5 mLs followed by a 50-mL bolus of saline solution Delayed-phase scans will be obtained 120-180 seconds after contrast injection All measurements will be taken in multiplanar reconstruction always in the plane perpendicular to the manually corrected local aortic centre line Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation The maximum aortic diameter mm will be measured from the outer contours of the aortic wall Normalized aortic diameter cmm2 will be calculated by dividing the maximum aortic diameter cm by the body surface area m2 The body surface area will be calculated based on the Mosteller formula body surface area m2 Height cm x Weight kg3600 Analysis and assessment of the images will be based on the consensus between two experienced investigators
Follow-up information will be collected using direct or phone contact with patients relatives or physicians
All surgical procedures will be performed via median sternotomy During the aortic arch anastomosis continuous unilateral SACP using innominate artery will be employed Unilateral SACP may be converted to bilateral ACP at the surgeons discretion if adequate cerebral flows are not achieved or if there are concerns with cerebral oximetry measurements
Once on CPB the patient will be cooled to a nasopharyngeal NP temperature of 28-30 C Rectal temperature with be monitored as an additional temperature sites Unilateral SACP will only be initiated once the target temperature has been reached SACP via the innominate artery will be commenced with target flows of 8-10 mlkgmin and perfusion pressure of 60-80 mmHg Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy NIRS
After completion of the aortic hemiarch replacement CPB will be resumed and the patient re-warmed to 36 C prior to coming off CPB with a 1 C temperature difference between temperature monitoring sites NP and rectal
Intraoperative information will be collected from the anesthetic record surgical notes and perfusion records Intraoperative data collection will include total operative time CPB time cross-clamp time hypothermic cardiac arrest time uSACP time lowest nasopharyngeal and rectal temperature arterial pressure in both radial arteries perfusion rate and perfusion pressure during both of CPB and unilateral SACP lowest hemoglobin concentration gL and hematocrit acid-base indices intraoperative red blood cell transfusion units highest doseagent used for intraoperative inotrope or vasopressor support Also during the surgery will be performed NIRS and BIS-monitoring
Postoperative data will include valuation of following indicators mortality hospital mortality and death from any cause neurological injury TIA stroke delirium MRI and CT-scan only in event of postoperative stroke acute kidney injury creatinine level prior and 1 2 4 postoperative day POD urine output-up to 24-48 h renal replacement therapy dialysis time of mechanical ventilation re-exploration for bleeding tamponade or other reasons postoperative transfusion packed red blood cells platelets fresh frozen platelets cryoprecipitate postoperative myocardial infarction electrocardiogram and troponins inotropic support during 24-48 h agent and dose VIS length of stay intensive care unit and total hospital days
In non-operted grop of patients annually echo cardiography CT scans will be performed
Aortic imaging All measurements will be taken using electrocardiography-gated computed tomographic angiography Analysis was performed using 64-slice scanner Discovery NM-CT 570c GE Healthcare Milwaukee WI USA with spatial resolution of the angiographic phase ranging from 06 to 125 mm Adopted computed tomographic protocol included unenhanced arterial and delayed data acquisition The arterial phase will be acquired after intravenous injection of 80-100 mL of nonionic iodinated contrast at 5 mLs followed by a 50-mL bolus of saline solution Delayed-phase scans will be obtained 120-180 seconds after contrast injection All measurements will be taken in multiplanar reconstruction always in the plane perpendicular to the manually corrected local aortic centre line Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation The maximum aortic diameter mm will be measured from the outer contours of the aortic wall Normalized aortic diameter cmm2 will be calculated by dividing the maximum aortic diameter cm by the body surface area m2 The body surface area will be calculated based on the Mosteller formula body surface area m2 Height cm x Weight kg3600 Analysis and assessment of the images will be based on the consensus between two experienced investigators
Follow-up information will be collected using direct or phone contact with patients relatives or physicians
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