Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery
ConditionHeart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHEPA University Hospital
About this trial
The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes.
Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded.
The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes.
Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older, irrespective of sex.
Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).
Anticipated adequate acoustic window for transthoracic echocardiography.
Provision of written informed consent.
Disqualifiers
- Emergency or unscheduled cardiac surgery.
Cardiac surgery without cardiopulmonary bypass (off-pump surgery).
Refusal or inability to provide written informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
BIS-guided anesthesia: BIS 45-55
Other interventionTotal intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.
BIS-guided anesthesia: BIS 30-35
Other interventionTotal intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: BIS 45-55Active comparator 1 intervention
Group B: BIS 30-35Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at two predefined intraoperative time points: T1, after induction of anesthesia and before initiation of cardiopulmonary bypass, and T2, after separation from cardiopulmonary bypass. The primary outcome will be the within-participant change in LV GLS, calculated as T2 minus T1 and expressed in percentage points. Because LV GLS is expressed as a negative value, a positive T2-minus-T1 difference indicates a reduction in the absolute magnitude of LV GLS and therefore deterioration in longitudinal systolic function.
Time frame
During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.Secondary outcomes
1
Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 by Randomized BIS Group
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The within-participant change in LV GLS (T2 minus T1), expressed in percentage points, will be compared between participants randomized to the BIS 45-55 and BIS 30-35 groups.
Time frame
During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.2
Change in Left Ventricular Myocardial Work Indices From T1 to T2 by Randomized BIS Group
Left ventricular myocardial work will be assessed using non-invasive pressure-strain loops at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. Myocardial work indices will include Global Work Index (GWI), Global Constructive Work (GCW), Global Wasted Work (GWW), and Global Work Efficiency (GWE). Changes from T1 to T2 will be assessed within participants and compared between the BIS 45-55 and BIS 30-35 groups.
Time frame
During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.3
Postoperative Adverse Clinical Events
Postoperative adverse clinical events will include the occurrence of low cardiac output syndrome (LCOS), requirement for inotropic or vasopressor support, and postoperative atrial fibrillation (POAF). Each event will be recorded during the postoperative hospitalization and evaluated in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
Time frame
From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.4
Duration of Mechanical Ventilation
The duration of postoperative mechanical ventilation will be recorded as the time from completion of index cardiac surgery until successful extubation. Duration will be expressed in minutes and analyzed in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
Time frame
From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov