Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589323
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Residents Learning Curve of Intraoperative Transit-time Flowmetry and High-frequency Ultrasound in CABG LEARNERS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiac Surgery Residents Learning Curve of Intraoperative Transit-time Flowmetry and High-frequency Ultrasound in Coronary Artery Bypass Surgery the LEARNERS Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEARNERS
Brief Summary:
Transit-time flowmetry TTFM allows grafts quality assessment during coronary artery bypass surgery by measuring the flow volume through them Recently the intraoperative epicardial high-frequency ultrasound HFUS was introduced with the possibility of capturing bidimensional images of the anastomoses When combined these two techniques provide high diagnostic yield reaching a positive predictive value of 100 percent
Despite current guidelines recommend the employment of TTFM and HFUS they remain largely underused probably because of limited information and the lack of standardization Furthermore surgeons must overcome a learning curve to handle both techniques properly but few data are available according the current literature
The main purpose of this study is to evaluate the complexity of HFUS and TTFM learning curve This is a prospective observational monocentric cohort study Adult patients undergoing coronary artery bypass surgery will be enrolled
Despite current guidelines recommend the employment of TTFM and HFUS they remain largely underused probably because of limited information and the lack of standardization Furthermore surgeons must overcome a learning curve to handle both techniques properly but few data are available according the current literature
The main purpose of this study is to evaluate the complexity of HFUS and TTFM learning curve This is a prospective observational monocentric cohort study Adult patients undergoing coronary artery bypass surgery will be enrolled
Detailed Description:
This is a prospective observational monocentric cohort study in which adult patients undergoing coronary artery bypass surgery will be enrolled
Primary objective of this study is to evaluate the complexity of cardiac surgery residents learning curve for grafts quality assessment with transit-time flowmetry TTFM and intraoperative epicardial high-frequency ultrasound HFUS
Secondary objectives are to evaluate the complexity of cardiac surgery residents learning curve for grafts quality assessment with TTFM and HFUS as isolated techniques
The study will last four months three months for patients enrollment and data collection and one month for statistical analysis and scientific paper writing
The trial will start after obtaining favourable opinion from the local Ethics Committee and could be considered completed when all the eight cardiac surgery residents involved have reached primary endpoint
All patients with coronary artery disease and an indication for surgical revascularization coronary artery bypass grafting who meet the above-described inclusion and exclusion criteria will be enrolled by signing the informed consent the day before surgery
Patient data anamnestic data surgery description intraoperative echographic and flowmetric measurements will be recorded in a dedicated database All data recorded in the database are commonly acquired for all patients undergoing this type of surgery and no further examinations will be performed for patients included in the trial
The study will involve cardiac surgery residents with different levels of training and an expert cardiac surgeon who acts as supervisor and benchmark Each resident will sign a dedicated informed consent form in the presence of a doctor foreign to the study protocol Cardiac Surgery ward cardiologist The residents will be blinded about the trial objective and the adopted score system They will undergo a specific training including a quick lesson and a practical workshop to familiarize with the equipment
During surgery every graft will be evaluated through transit time flowmetry TTFM and intraoperative ultrasound control HFUS
In details the ultrasound control is carried out through a dedicated sterile ultrasound probe connected to a machine MiraQ - MEDISTIM as soon as each anastomosis is completed The result of the evaluation is recorded together with surgery data This evaluation is intended to confirm the correct realization of the anastomosis and provides a proof of its patency
Once each graft is completed the resident will be given 60 seconds to acquire two HFUS recordings short and long axis After that the supervisor will perform his personal recording which will stand as benchmark The following items will be evaluated
A Long axis recording acquired within 60 seconds YES- 1 NO - 0 B Long axis recording judged as suitable by the supervisor YES - 1 NO - 0 C Short axis recording acquired within 60 seconds YES - 1 NO - 0 D Short axis recording judged as suitable by the supervisor YES - 1 NO - 0
E Correct interpretation of the anastomosis as adequate or inadequate YES - no penalty NO - total score becomes 0 and the resident isnt allowed to perform TTFM
Each resident will be given a HFUS-related score from a minimum of 0 to a maximum of 4
Whenever one of the recordings will be judged as non-suitable by the supervisor and consequently useless for a correct interpretation of the anastomosis score 0 for items A andor C item E wont be evaluated and the HFUS will be given a total score of 0
Next step will be the TFM evaluation which is carried out through a specific sterile device connected to the same machine MiraQ - MEDISTIM once the patient has been weaned from the cardiopulmonary bypass and before protamine administration This recording is performed under EKG and pressure-controlled conditions Although there is no general agreement on the optimal mean arterial pressure at which the measurement has to be recorded the investigators will adopt the standard used in the REQUEST study protocol 16 that is an average pressure of 80 mmHg
The resident will acquire the TTFM recording after each graft is completed To make the comparison as accurate as possible the resident will perform TTFM evaluation on one graft at a time and successively the supervisor will do the same for each graft making sure that delta between the pressure during the two recordings is lower than 10 percent and that no drug has been administered The following items will be evaluated
F Time necessary to acquire the measures 30 sec - 1 30 sec 60 - 05 60 sec - 0 G Need for multiple measurements before the final one 2 - 0 1 - 05 0 - 1 H Need to change probe dimensions NO - 0 YES- 1
I ACI delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 L Mean Flow delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 M Pulsatility Index delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 N Backward Flow delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 O Diastolic Filling delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0
P Correct interpretation of the graft quality as working YES - no penalty NO - total score becomes 0
Each resident will be given a TTFM-related score from a minimum of 0 to a maximum of 8
The final score for each graft will be the sum of the two scores HFUS and TTFM from a minimum of 0 to a maximum of 12
The same procedure will be repeated for each graft performed during the surgery
Each resident will continue until reaching a ratio between total score and number of evaluated anastomoses of 11
Our cardiac surgery unit performs between 5 and 10 coronary artery bypass grafts surgeries per week on average Considering the inclusion and exclusion criteria and assuming that some patient may not give their informed consent the investigators expect to enroll 4 patients per week Considering that the involved residents 8 in total will take part to the procedures in turn and that around 10 surgeries are needed to become autonomous the investigators estimate to enroll 80 patients during a period of 3 months
Data will be collected in a specific database Microsoft Excel worksheet The Kolgomorov-Smirnoff test was used to check for variables distribution Continuous variables with a normal distribution are summarized by mean and standard deviation Continuous variables with a non-normal distribution are expressed with median and interquartile range
Categorical variables are reported as absolute frequency distribution and percentage Continuous data are analyzed using the unpaired t-test or the Mann - Whitney test according to their distribution Categorical data are compared with the Fishers exact test Statistical findings were considered significant if p value was less than 005 Statistical analysis will be performed with the statistic software SPSS IBM
Primary objective of this study is to evaluate the complexity of cardiac surgery residents learning curve for grafts quality assessment with transit-time flowmetry TTFM and intraoperative epicardial high-frequency ultrasound HFUS
Secondary objectives are to evaluate the complexity of cardiac surgery residents learning curve for grafts quality assessment with TTFM and HFUS as isolated techniques
The study will last four months three months for patients enrollment and data collection and one month for statistical analysis and scientific paper writing
The trial will start after obtaining favourable opinion from the local Ethics Committee and could be considered completed when all the eight cardiac surgery residents involved have reached primary endpoint
All patients with coronary artery disease and an indication for surgical revascularization coronary artery bypass grafting who meet the above-described inclusion and exclusion criteria will be enrolled by signing the informed consent the day before surgery
Patient data anamnestic data surgery description intraoperative echographic and flowmetric measurements will be recorded in a dedicated database All data recorded in the database are commonly acquired for all patients undergoing this type of surgery and no further examinations will be performed for patients included in the trial
The study will involve cardiac surgery residents with different levels of training and an expert cardiac surgeon who acts as supervisor and benchmark Each resident will sign a dedicated informed consent form in the presence of a doctor foreign to the study protocol Cardiac Surgery ward cardiologist The residents will be blinded about the trial objective and the adopted score system They will undergo a specific training including a quick lesson and a practical workshop to familiarize with the equipment
During surgery every graft will be evaluated through transit time flowmetry TTFM and intraoperative ultrasound control HFUS
In details the ultrasound control is carried out through a dedicated sterile ultrasound probe connected to a machine MiraQ - MEDISTIM as soon as each anastomosis is completed The result of the evaluation is recorded together with surgery data This evaluation is intended to confirm the correct realization of the anastomosis and provides a proof of its patency
Once each graft is completed the resident will be given 60 seconds to acquire two HFUS recordings short and long axis After that the supervisor will perform his personal recording which will stand as benchmark The following items will be evaluated
A Long axis recording acquired within 60 seconds YES- 1 NO - 0 B Long axis recording judged as suitable by the supervisor YES - 1 NO - 0 C Short axis recording acquired within 60 seconds YES - 1 NO - 0 D Short axis recording judged as suitable by the supervisor YES - 1 NO - 0
E Correct interpretation of the anastomosis as adequate or inadequate YES - no penalty NO - total score becomes 0 and the resident isnt allowed to perform TTFM
Each resident will be given a HFUS-related score from a minimum of 0 to a maximum of 4
Whenever one of the recordings will be judged as non-suitable by the supervisor and consequently useless for a correct interpretation of the anastomosis score 0 for items A andor C item E wont be evaluated and the HFUS will be given a total score of 0
Next step will be the TFM evaluation which is carried out through a specific sterile device connected to the same machine MiraQ - MEDISTIM once the patient has been weaned from the cardiopulmonary bypass and before protamine administration This recording is performed under EKG and pressure-controlled conditions Although there is no general agreement on the optimal mean arterial pressure at which the measurement has to be recorded the investigators will adopt the standard used in the REQUEST study protocol 16 that is an average pressure of 80 mmHg
The resident will acquire the TTFM recording after each graft is completed To make the comparison as accurate as possible the resident will perform TTFM evaluation on one graft at a time and successively the supervisor will do the same for each graft making sure that delta between the pressure during the two recordings is lower than 10 percent and that no drug has been administered The following items will be evaluated
F Time necessary to acquire the measures 30 sec - 1 30 sec 60 - 05 60 sec - 0 G Need for multiple measurements before the final one 2 - 0 1 - 05 0 - 1 H Need to change probe dimensions NO - 0 YES- 1
I ACI delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 L Mean Flow delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 M Pulsatility Index delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 N Backward Flow delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0 O Diastolic Filling delta between resident and supervisor measurements 10- 1 10 20 - 05 20 - 0
P Correct interpretation of the graft quality as working YES - no penalty NO - total score becomes 0
Each resident will be given a TTFM-related score from a minimum of 0 to a maximum of 8
The final score for each graft will be the sum of the two scores HFUS and TTFM from a minimum of 0 to a maximum of 12
The same procedure will be repeated for each graft performed during the surgery
Each resident will continue until reaching a ratio between total score and number of evaluated anastomoses of 11
Our cardiac surgery unit performs between 5 and 10 coronary artery bypass grafts surgeries per week on average Considering the inclusion and exclusion criteria and assuming that some patient may not give their informed consent the investigators expect to enroll 4 patients per week Considering that the involved residents 8 in total will take part to the procedures in turn and that around 10 surgeries are needed to become autonomous the investigators estimate to enroll 80 patients during a period of 3 months
Data will be collected in a specific database Microsoft Excel worksheet The Kolgomorov-Smirnoff test was used to check for variables distribution Continuous variables with a normal distribution are summarized by mean and standard deviation Continuous variables with a non-normal distribution are expressed with median and interquartile range
Categorical variables are reported as absolute frequency distribution and percentage Continuous data are analyzed using the unpaired t-test or the Mann - Whitney test according to their distribution Categorical data are compared with the Fishers exact test Statistical findings were considered significant if p value was less than 005 Statistical analysis will be performed with the statistic software SPSS IBM
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