Hemodynamic ChangesNCT07109232
Surgical Position and Hemodynamics in PCNL
An observational study of Hemodynamic Changes and Surgical Positioning, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aims to evaluate the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamic Changes, Surgical Positioning, Percutaneous Nephrolithotomy (PCNL)
- What is being tested?
- Position the patient
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 15 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-65 years, classified as ASA physical status I-II, with BMI < 30, undergoing elective percutaneous nephrolithotomy (PCNL) under general anesthesia.
Who may be able to join
- Participants must be between 18 and 65 years of age. Participants must have a body mass index (BMI) of less than 30 kg/m². Participants must be classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Participants must be scheduled to undergo elective percutaneous nephrolithotomy (PCNL) surgery.
Who cannot join
- Participants with a known history of cardiac disease, including arrhythmia, valvular heart disease, prior cardiac surgery, presence of a pacemaker, or an implanted cardiac defibrillator, will be excluded.
- Participants with renal failure will be excluded. Participants who received colloid fluid administration prior to surgery will be excluded.
- Participants using vasoactive or inotropic drugs will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Medicine
Erzurum, 25100
About this study
Official title: Hemodynamic Effects of Surgical Positioning in Patients Undergoing Percutaneous Nephrolithotomy: A Prospective Study
This prospective study aims to evaluate the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). Hemodynamic parameters are assessed using the Pressure Recording Analytical Method (PRAM) both while patients are awake and under general anesthesia. The study investigates how positioning-independently and in combination with anesthesia-influences cardiovascular function, including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). The findings are expected to contribute to optimizing perioperative management and enhancing patient safety during PCNL procedures.
Read the detailed description
This prospective clinical trial investigates the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). The study evaluates hemodynamic variables both in the awake state and under general anesthesia to distinguish the individual and combined impacts of anesthesia and patient positioning on cardiovascular function.
Hemodynamic measurements are performed using the Pressure Recording Analytical Method (PRAM), a minimally invasive technique that allows continuous assessment of parameters such as mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (SVV), stroke volume index (SVI), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). Each patient is sequentially positioned in the three surgical positions while awake, and the same measurements are repeated after the induction of general anesthesia in the corresponding positions.
The primary aim is to determine how surgical positioning under general anesthesia alters key cardiovascular parameters. Secondary objectives include comparing hemodynamic changes across positions in both conscious and anesthetized states, identifying potential risks associated with specific positions, and guiding intraoperative patient management to improve safety and outcomes in PCNL procedures.
The study is conducted at a single center and includes adult patients with ASA physical status I-II scheduled for elective PCNL surgery. The findings are expected to provide valuable data for anesthesiologists and surgeons to optimize perioperative cardiovascular stability, particularly during position changes in urological surgeries.
- Being tested
- Position the patient
- Keywords
- Nephrolithotomy, Hemodynamics, Surgical position, Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position the patientOther
In addition, prior to the operation and throughout the PCNL procedure, hemodynamic measurements were obtained while patients were positioned in the supine, lithotomy, and prone positions, as necessitated by the surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic Response to Position Changes | Hemodynamic variables-including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), dP/dtmax, arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power index (CPI)-were continuously monitored. Hemodynamic measurements were obtained at six predefined time points using the Pressure Recording Analytical Method (PRAM).
The first three measurements were recorded during the pre-anesthetic period in the supine, lithotomy, and prone positions, respectively, prior to the induction of anesthesia. The latter three measurements were obtained during the anesthetized period: five minutes after induction while the patient was in the baseline supine position, five minutes after transitioning to the lithotomy position (prior to ureteral catheter placement), and five minutes after repositioning to the prone position, before surgical incision. Receives: Other: Position the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of supine, lithotomy, and prone position on cardiac cycle efficiency (CCE) during the anesthetic period.
The primary objective was to evaluate the effects of different surgical positions on cardiac cycle efficiency (CCE), a parameter derived from pulse contour analysis during the anesthetic period. First measurement was recorded five minutes after anesthesia induction, while the patient was in the baseline supine position. Second measurement was recorded five minutes after transitioning to the lithotomy position, prior to ureteral catheter insertion. The third measurement was recorded five minutes after repositioning to the prone position
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Secondary outcomes (17)
Mean Arterial Pressure assessment
Mean Arterial Pressure (MAP), derived via the PRAM method, was assessed in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Heart Rate (HR) Assessment
Heart Rate (HR) was recorded using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Index (CI) Assessment
Cardiac Index (CI) was measured using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Stroke Volume Index (SVI) Assessment
Stroke Volume Index (SVI) was assessed via the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
dP/dt max Assessment
dP/dt max, an index of cardiac contractility, was assessed using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Arterial Elastance (Ea) Assessment
Arterial Elastance (Ea) was measured using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Cycle Efficiency (CCE) Assessment
Cardiac Cycle Efficiency (CCE) was derived using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Power Index (CPI) Assessment
Cardiac Power Index (CPI) was assessed using the PRAM method in awake patients at three predefined surgical positions.
Measured: Pre-anesthetic period at three predefined time points: 1) before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Mean Arterial Pressure (MAP) Assessment under General Anesthesia
Mean Arterial Pressure (MAP) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Heart Rate (HR) Assessment under General Anesthesia
Heart Rate (HR) was recorded using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Cardiac Index (CI) Assessment under General Anesthesia
Cardiac Index (CI) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Stroke Volume Index (SVI) Assessment under General Anesthesia
Stroke Volume Index (SVI) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Pulse Pressure Variation (PPV) Assessment under General Anesthesia
Pulse Pressure Variation (PPV) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Stroke Volume Variation (SVV) Assessment under General Anesthesia
Stroke Volume Variation (SVV) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
dP/dt max Assessment under General Anesthesia
dP/dt max, an index of cardiac contractility, was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Arterial Elastance (Ea) Assessment under General Anesthesia
Arterial Elastance (Ea) was measured using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Cardiac Power Index (CPI) Assessment under General Anesthesia
Cardiac Power Index (CPI) was assessed using the PRAM method in patients under general anesthesia at three surgical positions in the operating room.
Measured: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 May 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic ChangesStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Cem ÇELİK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109232
- Sponsor's protocol ID
- Ataunihemo
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.
PubMed 38794845Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.
PubMed 28012725
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Surgical Positioning in Patients Undergoing Percutaneous Nephrolithotomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07109232
- Acronym / sponsor ID
- Ataunihemo
- Keywords
- Nephrolithotomy, Hemodynamics, Surgical position, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 7 Aug 2025 (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.
This prospective study aims to evaluate the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). Hemodynamic parameters are assessed using the Pressure Recording Analytical Method (PRAM) both while patients are awake and under general anesthesia. The study investigates how positioning-independently and in combination with anesthesia-influences cardiovascular function, including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). The findings are expected to contribute to optimizing perioperative management and enhancing patient safety during PCNL procedures.
Detailed description
This prospective clinical trial investigates the hemodynamic effects of different surgical positions-supine, lithotomy, and prone-in patients undergoing percutaneous nephrolithotomy (PCNL). The study evaluates hemodynamic variables both in the awake state and under general anesthesia to distinguish the individual and combined impacts of anesthesia and patient positioning on cardiovascular function.
Hemodynamic measurements are performed using the Pressure Recording Analytical Method (PRAM), a minimally invasive technique that allows continuous assessment of parameters such as mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (SVV), stroke volume index (SVI), cardiac contractility parameters (dP/dtmax), arterial elastance (Ea), cardiac power index (CPI), and cardiac cycle efficiency (CCE). Each patient is sequentially positioned in the three surgical positions while awake, and the same measurements are repeated after the induction of general anesthesia in the corresponding positions.
The primary aim is to determine how surgical positioning under general anesthesia alters key cardiovascular parameters. Secondary objectives include comparing hemodynamic changes across positions in both conscious and anesthetized states, identifying potential risks associated with specific positions, and guiding intraoperative patient management to improve safety and outcomes in PCNL procedures.
The study is conducted at a single center and includes adult patients with ASA physical status I-II scheduled for elective PCNL surgery. The findings are expected to provide valuable data for anesthesiologists and surgeons to optimize perioperative cardiovascular stability, particularly during position changes in urological surgeries.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic Response to Position Changes | – | Other: Position the patientHemodynamic variables-including mean arterial pressure (MAP), heart rate (HR), cardiac index (CI), stroke volume index (SVI), pulse pressure variation (PPV), stroke volume variation (SVV), dP/dtmax, arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power index (CPI)-were continuously monitored. Hemodynamic measurements were obtained at six predefined time points using the Pressure Recording Analytical Method (PRAM). The first three measurements were recorded during the pre-anesthetic period in the supine, lithotomy, and prone positions, respectively, prior to the induction of anesthesia. The latter three measurements were obtained during the anesthetized period: five minutes after induction while the patient was in the baseline supine position, five minutes after transitioning to the lithotomy position (prior to ureteral catheter placement), and five minutes after repositioning to the prone position, before surgical incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-65 years, classified as ASA physical status I-II, with BMI < 30, undergoing elective percutaneous nephrolithotomy (PCNL) under general anesthesia.
Key inclusion criteria (2 listed)
- Participants must be between 18 and 65 years of age. Participants must have a body mass index (BMI) of less than 30 kg/m². Participants must be classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Participants must be scheduled to undergo elective percutaneous nephrolithotomy (PCNL) surgery.
Key exclusion criteria (3 listed)
- Participants with a known history of cardiac disease, including arrhythmia, valvular heart disease, prior cardiac surgery, presence of a pacemaker, or an implanted cardiac defibrillator, will be excluded.
- Participants with renal failure will be excluded. Participants who received colloid fluid administration prior to surgery will be excluded.
- Participants using vasoactive or inotropic drugs will be excluded.
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 |
|---|---|---|
| Position the patientIn addition, prior to the operation and throughout the PCNL procedure, hemodynamic measurements were obtained while patients were positioned in the supine, lithotomy, and prone positions, as necessitated by the surgical protocol. | Other | Hemodynamic Response to Position Changes |
Primary outcome
Evaluate the effects of supine, lithotomy, and prone position on cardiac cycle efficiency (CCE) during the anesthetic period.
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
The primary objective was to evaluate the effects of different surgical positions on cardiac cycle efficiency (CCE), a parameter derived from pulse contour analysis during the anesthetic period. First measurement was recorded five minutes after anesthesia induction, while the patient was in the baseline supine position. Second measurement was recorded five minutes after transitioning to the lithotomy position, prior to ureteral catheter insertion. The third measurement was recorded five minutes after repositioning to the prone position
17 secondary outcomes
Mean Arterial Pressure assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Heart Rate (HR) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Index (CI) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Stroke Volume Index (SVI) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
dP/dt max Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Arterial Elastance (Ea) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Cycle Efficiency (CCE) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) Before anesthesia induction in the supine position, 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Cardiac Power Index (CPI) Assessment
Time frame: Pre-anesthetic period at three predefined time points: 1) before anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position (while still awake) 3) 5 minutes after transitioning to prone position (before induction)
Mean Arterial Pressure (MAP) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Heart Rate (HR) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Cardiac Index (CI) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Stroke Volume Index (SVI) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Pulse Pressure Variation (PPV) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Stroke Volume Variation (SVV) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
dP/dt max Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Arterial Elastance (Ea) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
Cardiac Power Index (CPI) Assessment under General Anesthesia
Time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position
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 7 Aug 2025.
- Background: PubMed 38794845Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.
- Background: PubMed 28012725Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.
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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 Changes and Surgical Positioning, run by Ataturk 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 2 inclusion and 3 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 7 Aug 2025. 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?
Evaluate the effects of supine, lithotomy, and prone position on cardiac cycle efficiency (CCE) during the anesthetic period. (time frame: Intraoperative period (under general anesthesia) at three predefined time points: 1) 5 minutes after anesthesia induction in the supine position 2) 5 minutes after transitioning to lithotomy position 3) 5 minutes after repositioning to prone position). 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 NCT07109232, which also lists 2 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 7 Aug 2025.