AnesthesiaNCT05558826
Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure
An observational study of Anesthesia and Fluid and Electrolyte Imbalance, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Anesthesia, Fluid and Electrolyte Imbalance, Hemodynamic Instability
- What is being tested?
- HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2022to 1 Oct 2024
- 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: The investigators plan to enroll patients who will laparoscopic surgery under general anesthesia. These patients will be screened for eligibility.
Who may be able to join
- Patients aged between 20 and 80
- Scheduled for laparoscopic surgery
- American Society of Anesthesiologists (ASA) physical status I to III.
Who cannot join
- Neurologic or behavioral disorders
- American Society of Anesthesiologists (ASA) physical status ≥ IV
- History of arrhythmia
- Drug abuse or alcoholism
- Resting room air SpO2 < 90%.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11257
About this study
Official title: Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Thus, maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes. Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies. However, dynamic indices of arterial pressure waveform analysis such as pulse pressure variation (PPV) and stroke volume variation (SVV) are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position. Intravascular fluid status might thus be misinterpreted. Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal, gynecological, and genitourinary procedures. Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management. This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform.
Read the detailed description
In this prospective observational study, the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including electrocardiography, photo-plethysmography , blood pressure, neurological system information (Bispectral index and Density spectral array ), the respiratory gas monitoring (gas analyzer and respiratory waveform) and dynamic indices of arterial pressure waveform analysis (cardiac index, stroke volume variation, pulse pressure variation, hypotension prediction index... etc.) from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences) every 20 seconds.
After anesthesia induction as routine clinical practice, slow IV fluid infusion will be maintained. The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree. CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. The recording is ended after emergence when surgery ends. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. Methods including signal processing, modeling, classification will be used.
- Being tested
- HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software
- Keywords
- Goal directed fluid therapy, Arterial waveform analysis, Pneumoperitoneum, Trendelenburg position
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index SoftwareDevice
After induction of anesthesia, intra-arterial catheterization will be done for invasive blood pressure monitoring and blood sampling as routine clinical practice for major laparoscopic surgery. Arterial line will be connected to HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software for arterial pressure waveform analysis. Dynamic indices including pulse pressure variation (PPV), stroke volume variation (SVV), Hypotension Prediction Index (HPI), Dynamic arterial elastance (Eadyn) and dP/dt will be continuously recorded. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. Data analysis and statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation (SVV)
SVV is the ratio of the maximum (SVmax) SV minus the minimum SV (SVmin) to the mean SV (SVmean), averaged over several respiratory cycles. SVV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested SVV >10 % is associated with fluid responsiveness. SVV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Measured: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Pulse pressure variation (PPV)
PPV is the ratio of the maximum pulse pressure (systolic blood pressure minus diastolic blood pressure; PPmax) minus the minimum pulse pressure (PPmin) to the mean pulse pressure (PPmean), averaged over several respiratory cycles. PPV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested PPV >13-15 %is associated with fluid responsiveness. PPV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Measured: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Hypotension Prediction Index (HPI)
The Hypotension Prediction Index (HPI) is a prediction model based on features of arterial pressure waveform. It represents as unitless number from 1 to 100. Greater number suggested higher risk of a hypotension event occurring in the future. HPI will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Measured: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Dynamic arterial elastance (Eadyn)
Dynamic arterial elastance (Eadyn) is the ratio of pulse pressure variations (PPV) to stroke volume variations (SVV). Studies have shown Eadyn as a predictor of blood pressure response to fluid resuscitation in hypotension, fluid-responsive patients. Eadyn will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Measured: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
dP/dt
dP/dT (mmHg/second)is the change of left ventricular pressure over time during isovolemic contraction. It is usually used as a predictor of myocardial contractility.
Measured: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Secondary outcomes (1)
Bispectral index (BIS) value
Our study records these parameters on an observational basis. Anesthetic management remains identical regardless of patient participation or not. The recorded BIS value reading is uniform and contains only a unitless number ranging from 0 to 100. Different procedures do not give different units. Spectral analysis of the alpha, beta, gamma, theta and delta features of EEG will be performed. Individual band powers are summed separately.
Measured: BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chien-Kun Ting, MD.PhD, Study chair, Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558826
- Sponsor's protocol ID
- 2022-04-002AC
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
PubMed 34916049Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
PubMed 32960954Min JH, Lee SE, Lee HS, Chae YK, Lee YK, Kang Y, Je UJ. The correlation between the Trendelenburg position and the stroke volume variation. Korean J Anesthesiol. 2014 Dec;67(6):378-83. doi: 10.4097/kjae.2014.67.6.378. Epub 2014 Dec 29.
PubMed 25558337Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.
PubMed 30896602Tavernier B, Robin E. Assessment of fluid responsiveness during increased intra-abdominal pressure: keep the indices, but change the thresholds. Crit Care. 2011;15(2):134. doi: 10.1186/cc10074. Epub 2011 Mar 18.
PubMed 21457517
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
- ClinicalTrials.gov ID
- NCT05558826
- Acronym / sponsor ID
- 2022-04-002AC
- Keywords
- Goal directed fluid therapy, Arterial waveform analysis, Pneumoperitoneum, Trendelenburg position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 28 Sep 2022 (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.
Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Thus, maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes. Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies. However, dynamic indices of arterial pressure waveform analysis such as pulse pressure variation (PPV) and stroke volume variation (SVV) are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position. Intravascular fluid status might thus be misinterpreted. Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal, gynecological, and genitourinary procedures. Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management. This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform.
Detailed description
In this prospective observational study, the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including electrocardiography, photo-plethysmography , blood pressure, neurological system information (Bispectral index and Density spectral array ), the respiratory gas monitoring (gas analyzer and respiratory waveform) and dynamic indices of arterial pressure waveform analysis (cardiac index, stroke volume variation, pulse pressure variation, hypotension prediction index... etc.) from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences) every 20 seconds.
After anesthesia induction as routine clinical practice, slow IV fluid infusion will be maintained. The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree. CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. The recording is ended after emergence when surgery ends. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. Methods including signal processing, modeling, classification will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to enroll patients who will laparoscopic surgery under general anesthesia. These patients will be screened for eligibility.
Key inclusion criteria (3 listed)
- Patients aged between 20 and 80
- Scheduled for laparoscopic surgery
- American Society of Anesthesiologists (ASA) physical status I to III.
Key exclusion criteria (5 listed)
- Neurologic or behavioral disorders
- American Society of Anesthesiologists (ASA) physical status ≥ IV
- History of arrhythmia
- Drug abuse or alcoholism
- Resting room air SpO2 < 90%.
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 |
|---|---|---|
| HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index SoftwareAfter induction of anesthesia, intra-arterial catheterization will be done for invasive blood pressure monitoring and blood sampling as routine clinical practice for major laparoscopic surgery. Arterial line will be connected to HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software for arterial pressure waveform analysis. Dynamic indices including pulse pressure variation (PPV), stroke volume variation (SVV), Hypotension Prediction Index (HPI), Dynamic arterial elastance (Eadyn) and dP/dt will be continuously recorded. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. Data analysis and statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. | Device | – |
Primary outcome
Stroke volume variation (SVV)
Time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
SVV is the ratio of the maximum (SVmax) SV minus the minimum SV (SVmin) to the mean SV (SVmean), averaged over several respiratory cycles. SVV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested SVV >10 % is associated with fluid responsiveness. SVV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Pulse pressure variation (PPV)
Time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
PPV is the ratio of the maximum pulse pressure (systolic blood pressure minus diastolic blood pressure; PPmax) minus the minimum pulse pressure (PPmin) to the mean pulse pressure (PPmean), averaged over several respiratory cycles. PPV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested PPV >13-15 %is associated with fluid responsiveness. PPV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Hypotension Prediction Index (HPI)
Time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
The Hypotension Prediction Index (HPI) is a prediction model based on features of arterial pressure waveform. It represents as unitless number from 1 to 100. Greater number suggested higher risk of a hypotension event occurring in the future. HPI will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Dynamic arterial elastance (Eadyn)
Time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Dynamic arterial elastance (Eadyn) is the ratio of pulse pressure variations (PPV) to stroke volume variations (SVV). Studies have shown Eadyn as a predictor of blood pressure response to fluid resuscitation in hypotension, fluid-responsive patients. Eadyn will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
dP/dt
Time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
dP/dT (mmHg/second)is the change of left ventricular pressure over time during isovolemic contraction. It is usually used as a predictor of myocardial contractility.
1 secondary outcome
Bispectral index (BIS) value
Time frame: BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 34916049Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
- Background: PubMed 32960954Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
- Background: PubMed 25558337Min JH, Lee SE, Lee HS, Chae YK, Lee YK, Kang Y, Je UJ. The correlation between the Trendelenburg position and the stroke volume variation. Korean J Anesthesiol. 2014 Dec;67(6):378-83. doi: 10.4097/kjae.2014.67.6.378. Epub 2014 Dec 29.
- Background: PubMed 30896602Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.
- Background: PubMed 21457517Tavernier B, Robin E. Assessment of fluid responsiveness during increased intra-abdominal pressure: keep the indices, but change the thresholds. Crit Care. 2011;15(2):134. doi: 10.1186/cc10074. Epub 2011 Mar 18.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Chien-Kun Ting, MD.PhD study chair
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
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 Anesthesia and Fluid and Electrolyte Imbalance, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Kun Ting, MD.PhD (+886-938593137, ckting@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume variation (SVV) (time frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends). The study lists 5 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 NCT05558826, which also lists 5 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 28 Sep 2022.