Hemodynamic InstabilityNCT05685979
Evaluation of Cardiac Functions in Deep Trendelenburg Position
An observational study of Hemodynamic Instability and Cardiovascular Complication, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Robotic-assisted laparoscopic prostatectomy (RALP) is a surgical method with good short-term results and accepted as the gold standard because of its minimal invasiveness. The pneumoperitoneum and deep Trendelenburg position (at least 25°-45° upside down) required for RALP surgeries can cause significant… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Hemodynamic Instability, Cardiovascular Complication
- What is being tested?
- Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with intra-arterial blood pressure monitoring before anesthesia induction
Who may be able to join
- Patients with American Society Of Anesthesiology physical status 1-3
- Underwent Robotic-assisted laparoscopic prostatectomy
- Patients with intra-arterial blood pressure monitoring before anesthesia induction.
- .Exclusion Criteria:
- Under 18 years of age
- Arrhythmia (atrial fibrillation, frequent premature beat)
Show all 11Show fewer
- History of myocardial infarction in the last 3 months
- Heart failure
- Severe pre-existing lung disease
- Severe valvular heart disease
- Chronic renal disease on dialysis,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiac Functions in Robotic-assisted Prostatectomy Surgery Performed Under Deep Trendelenburg Position
Robotic-assisted laparoscopic prostatectomy (RALP) is a surgical method with good short-term results and accepted as the gold standard because of its minimal invasiveness. The pneumoperitoneum and deep Trendelenburg position (at least 25°-45° upside down) required for RALP surgeries can cause significant pathophysiological changes in both the pulmonary and cardiac systems, as well as complicate hemodynamic management.
In this study, investigators aimed to determine the changes in the cardiovascular system during deep Trendelenburg position with the hemodynamic parameters monitored by the pressure record analytical method (PRAM) and the Longitudinal Strain measured with simultaneous transesophageal echocardiography.
Read the detailed description
RALP is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position. However, the possible side effects of the deep Trendelenburg position on the cardiovascular system during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Although the increase in venous return is expected to protect the cardiac output (CO) in the deep Trendelenburg position, the increase in intrathoracic pressure due to the intraperitoneal pressure may cause deterioration in venous return and a decrease in CO . In addition, the changing heart configuration in the deep Trendelenburg position may also cause an increase in the workload of the heart. Therefore, the need to evaluate hemodynamic management with advanced monitoring techniques, including fluid therapy in the perioperative period, has arisen in patients undergoing RALP.
The pressure Recording Analytical Method (PRAM), is one of the most up-to-date monitoring methods designed for continuous CO measurement derived from the arterial pressure wave analysis, with a high signal sampling rate (1000 Hz). Many studies have shown that PRAM is a reliable monitoring method in major surgery. Cardiac Cycle Efficiency (CCE), which the PRAM method adds to our daily practice, is an index that defines hemodynamic performance in terms of energy consumption and efficiency. It can be expressed as the ratio of systolic energy performance to the total energy expenditure of the cardiac cycle and indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. However, data on how cardiac functions change in the deep Trendelenburg position are still limited.
In this study, investigators aimed to demonstrate the reliability of the CCE value through its correlation with the Longitudinal Strain (LS) by observing the effect of the deep Trendelenburg position in RALP surgeries on cardiac functions using PRAM and Transesophageal Echocardiography (TEE).
- Being tested
- Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.
- Keywords
- Deep Trendelenburg position, Robotic-assisted laparoscopic prostatectomy, Pressure recording analytical method, Transesophageal echocardiography, Cardiac cycle efficiency, Longitudinal Strain, Hemodynamic monitorization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.Procedure or surgery
After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. | Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. Receives: Procedure: Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performance
CCE(unit) indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. CCE was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy)
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Longitudinal strain (LS) was measured for evaluating cardiac performance
LS (%) is a parameter that shows the percentage of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LS was calculated by intraoperative transesophageal echocardiography.
Measured: LS was measured at supine position and 10 minute after trendelenburg position
Longitudinal strain rate (LSR) was measured for evaluating cardiac performance
LSR (%) is a parameter that shows the rate of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LSR was calculated by intraoperative transesophageal echocardiography.
Measured: LSR was measured at supine position and 10 minute after trendelenburg position
Secondary outcomes (10)
Stroke volume variation (SVV) was measured for evaluation of volume status
Stroke volume variation (SVV,%), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVV is a parameter used to asses cardiac preload and fluid responsiveness.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Pulse pressure variation (PPV) was measured for evaluation of volume status
Pulse pressure variation (PPV,%) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). PPV is a parameter used to asses cardiac preload and fluid responsiveness.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac power output (CPO) was measured for evaluation of cardiac power reserve
Cardiac power output (CPO, Watt) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CPO is a parameter used to asses cardiac reserve
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac index (CI) was measured for evaluating cardiac flow
Cardiac index (CI, L/min/m2), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CI is a parameter used to asses cardiac stroke volume
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Dp/Dt was measured to assess cardiac systolic function
Dp/Dt(mmHg/msn), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). Dp/Dt is a parameter used to asses cardiac contractility.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure
Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Mean arterial pressure (MAP) was measured for evaluating perfusion pressure
Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Heart rate (HR) was measured for evaluating heart ritm
Heart rate( HR, bpm) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). HR is a parameter used to assess the cardiac rate.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systemic vascular resistance index (SVRI) was measured for evaluating peripheric vascular resistance
Systemic vascular resistance index (SVRI, dyn*s/cm5*m2) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVRI is a parameter used to assess the resistance to blood flow offered by all of the systemic vasculatures, excluding the pulmonary vasculature.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 May 2022
- Primary completion30 Sep 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685979
- Sponsor's protocol ID
- ATADEK; 2022-20/05
- Status last verified
- Jul 2023
- First submitted
- 6 Jan 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porpiglia F, Morra I, Lucci Chiarissi M, Manfredi M, Mele F, Grande S, Ragni F, Poggio M, Fiori C. Randomised controlled trial comparing laparoscopic and robot-assisted radical prostatectomy. Eur Urol. 2013 Apr;63(4):606-14. doi: 10.1016/j.eururo.2012.07.007. Epub 2012 Jul 20.
PubMed 22840353Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
PubMed 18200624Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
PubMed 21233502Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.
PubMed 33020097Ruppert M, Lakatos BK, Braun S, Tokodi M, Karime C, Olah A, Sayour AA, Hizoh I, Barta BA, Merkely B, Kovacs A, Radovits T. Longitudinal Strain Reflects Ventriculoarterial Coupling Rather Than Mere Contractility in Rat Models of Hemodynamic Overload-Induced Heart Failure. J Am Soc Echocardiogr. 2020 Oct;33(10):1264-1275.e4. doi: 10.1016/j.echo.2020.05.017. Epub 2020 Aug 7.
PubMed 32778499Faragli A, Tanacli R, Kolp C, Abawi D, Lapinskas T, Stehning C, Schnackenburg B, Lo Muzio FP, Fassina L, Pieske B, Nagel E, Post H, Kelle S, Alogna A. Cardiovascular magnetic resonance-derived left ventricular mechanics-strain, cardiac power and end-systolic elastance under various inotropic states in swine. J Cardiovasc Magn Reson. 2020 Nov 30;22(1):79. doi: 10.1186/s12968-020-00679-z.
PubMed 33256761
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Functions in Robotic-assisted Prostatectomy Surgery Performed Under Deep Trendelenburg Position
- ClinicalTrials.gov ID
- NCT05685979
- Acronym / sponsor ID
- ATADEK; 2022-20/05
- Keywords
- Deep Trendelenburg position, Robotic-assisted laparoscopic prostatectomy, Pressure recording analytical method, Transesophageal echocardiography, Cardiac cycle efficiency, Longitudinal Strain, Hemodynamic monitorization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic-assisted laparoscopic prostatectomy (RALP) is a surgical method with good short-term results and accepted as the gold standard because of its minimal invasiveness. The pneumoperitoneum and deep Trendelenburg position (at least 25°-45° upside down) required for RALP surgeries can cause significant pathophysiological changes in both the pulmonary and cardiac systems, as well as complicate hemodynamic management.
In this study, investigators aimed to determine the changes in the cardiovascular system during deep Trendelenburg position with the hemodynamic parameters monitored by the pressure record analytical method (PRAM) and the Longitudinal Strain measured with simultaneous transesophageal echocardiography.
Detailed description
RALP is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position. However, the possible side effects of the deep Trendelenburg position on the cardiovascular system during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Although the increase in venous return is expected to protect the cardiac output (CO) in the deep Trendelenburg position, the increase in intrathoracic pressure due to the intraperitoneal pressure may cause deterioration in venous return and a decrease in CO . In addition, the changing heart configuration in the deep Trendelenburg position may also cause an increase in the workload of the heart. Therefore, the need to evaluate hemodynamic management with advanced monitoring techniques, including fluid therapy in the perioperative period, has arisen in patients undergoing RALP.
The pressure Recording Analytical Method (PRAM), is one of the most up-to-date monitoring methods designed for continuous CO measurement derived from the arterial pressure wave analysis, with a high signal sampling rate (1000 Hz). Many studies have shown that PRAM is a reliable monitoring method in major surgery. Cardiac Cycle Efficiency (CCE), which the PRAM method adds to our daily practice, is an index that defines hemodynamic performance in terms of energy consumption and efficiency. It can be expressed as the ratio of systolic energy performance to the total energy expenditure of the cardiac cycle and indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. However, data on how cardiac functions change in the deep Trendelenburg position are still limited.
In this study, investigators aimed to demonstrate the reliability of the CCE value through its correlation with the Longitudinal Strain (LS) by observing the effect of the deep Trendelenburg position in RALP surgeries on cardiac functions using PRAM and Transesophageal Echocardiography (TEE).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. | – | Procedure: Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with intra-arterial blood pressure monitoring before anesthesia induction
Key inclusion criteria (11 listed)
- Patients with American Society Of Anesthesiology physical status 1-3
- Underwent Robotic-assisted laparoscopic prostatectomy
- Patients with intra-arterial blood pressure monitoring before anesthesia induction.
- Under 18 years of age
- Arrhythmia (atrial fibrillation, frequent premature beat)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down). | Procedure or surgery | Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. |
Primary outcome
Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performance
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
CCE(unit) indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. CCE was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy)
Longitudinal strain (LS) was measured for evaluating cardiac performance
Time frame: LS was measured at supine position and 10 minute after trendelenburg position
LS (%) is a parameter that shows the percentage of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LS was calculated by intraoperative transesophageal echocardiography.
Longitudinal strain rate (LSR) was measured for evaluating cardiac performance
Time frame: LSR was measured at supine position and 10 minute after trendelenburg position
LSR (%) is a parameter that shows the rate of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LSR was calculated by intraoperative transesophageal echocardiography.
10 secondary outcomes
Stroke volume variation (SVV) was measured for evaluation of volume status
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Pulse pressure variation (PPV) was measured for evaluation of volume status
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac power output (CPO) was measured for evaluation of cardiac power reserve
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac index (CI) was measured for evaluating cardiac flow
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Dp/Dt was measured to assess cardiac systolic function
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Mean arterial pressure (MAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Heart rate (HR) was measured for evaluating heart ritm
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systemic vascular resistance index (SVRI) was measured for evaluating peripheric vascular resistance
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 22840353Porpiglia F, Morra I, Lucci Chiarissi M, Manfredi M, Mele F, Grande S, Ragni F, Poggio M, Fiori C. Randomised controlled trial comparing laparoscopic and robot-assisted radical prostatectomy. Eur Urol. 2013 Apr;63(4):606-14. doi: 10.1016/j.eururo.2012.07.007. Epub 2012 Jul 20.
- Background: PubMed 18200624Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
- Background: PubMed 21233502Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
- Background: PubMed 33020097Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.
- Background: PubMed 32778499Ruppert M, Lakatos BK, Braun S, Tokodi M, Karime C, Olah A, Sayour AA, Hizoh I, Barta BA, Merkely B, Kovacs A, Radovits T. Longitudinal Strain Reflects Ventriculoarterial Coupling Rather Than Mere Contractility in Rat Models of Hemodynamic Overload-Induced Heart Failure. J Am Soc Echocardiogr. 2020 Oct;33(10):1264-1275.e4. doi: 10.1016/j.echo.2020.05.017. Epub 2020 Aug 7.
- Background: PubMed 33256761Faragli A, Tanacli R, Kolp C, Abawi D, Lapinskas T, Stehning C, Schnackenburg B, Lo Muzio FP, Fassina L, Pieske B, Nagel E, Post H, Kelle S, Alogna A. Cardiovascular magnetic resonance-derived left ventricular mechanics-strain, cardiac power and end-systolic elastance under various inotropic states in swine. J Cardiovasc Magn Reson. 2020 Nov 30;22(1):79. doi: 10.1186/s12968-020-00679-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability and Cardiovascular Complication, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performance (time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685979, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.