Abdominal CancerNCT06293391
The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery
An observational study of Abdominal Cancer and Blood Pressure, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Cancer, Blood Pressure, Cardiac Indices
- What is being tested?
- cardiac indices in supine and trendelenburg position
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 5 Feb 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients included in the study were intubated after standard anaesthesia induction with fentanyl 2 mcg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg, and ODM was used for case follow-up. All patients were followed with standard 6% desflurane anaesthetic gas and intravenous infusion of remifentanil, a short-acting opioid, after intubation. Mean arterial pressure was kept in the range of 65-80 mmHg in all patients, tidal volume was adjusted as 6-8 ml/kg, peep (positive end expiratory pressure) as 0-6 cm H2O and respiratory frequency as 10-15 /min for normocapnia. After intubation, intraoperative ODM measurements and intraoperative ODM measurements were retrospectively scanned and recorded in the supine and 45-degree angle trendelenburg position.
Who may be able to join
- Elective operation
- ASA 1-4
Who cannot join
- Heart failure
- Valvular heart disease,
- Patients with symptomatic rhythm disturbances
- ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital
Ankara, 06200
About this study
Official title: The Impact of Patient Position Changes on Advanced Hemodynamic Indices in Laparoscopic and Open Major Abdominal Cancer Surgeries
Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM.
Read the detailed description
Patients who underwent major abdominal cancer surgery using ODM in the operating room of our hospital between November 2021 and November 2022 were identified from the Anesthesiology Clinic records and examined according to whether they were operated with open or closed (laparoscopic) methods. Demographic data, vital signs, amount of bleeding, type and amount of fluid administered, and the results of cardiac index measurements performed with the ODM device in the supine and trendelenburg positions (45 degrees) were analyzed. Parameters recorded with the ODM device; CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance.
- Conditions
- Abdominal Cancer, Blood Pressure, Cardiac Indices
- Being tested
- cardiac indices in supine and trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac indices in supine and trendelenburg positionProcedure or surgery
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| ODM measurements of patients undergoing open surgery in supine and trendelenburg position | After intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded. Receives: Procedure: cardiac indices in supine and trendelenburg position | |
| ODM measurements of patients undergoing laparoscopic surgery in supine and trendelenburg position | After intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded. Receives: Procedure: cardiac indices in supine and trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Stroke Volume
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Flow time corrected
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Peak Velocity
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Stroke Distance
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Mean arterial pressure
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Pulse
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Measured: Immediately after induction of anaesthesia and at any stable time during the case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Feb 2023
- Primary completion1 Mar 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Mustafa Kemal SAHIN, M.D, Principal investigator, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293391
- Sponsor's protocol ID
- 2022-11/2097
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heinink TP, Read DJ, Mitchell WK, Bhalla A, Lund JN, Phillips BE, Williams JP. Oesophageal Doppler guided optimization of cardiac output does not increase visceral microvascular blood flow in healthy volunteers. Clin Physiol Funct Imaging. 2018 Mar;38(2):213-219. doi: 10.1111/cpf.12401. Epub 2017 Feb 6.
PubMed 28168868Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.
PubMed 29208025Haas S, Haese A, Goetz AE, Kubitz JC. Haemodynamics and cardiac function during robotic-assisted laparoscopic prostatectomy in steep Trendelenburg position. Int J Med Robot. 2011 Dec;7(4):408-13. doi: 10.1002/rcs.410. Epub 2011 Aug 3.
PubMed 21815239Conway DH, Hussain OA, Gall I. A comparison of noninvasive bioreactance with oesophageal Doppler estimation of stroke volume during open abdominal surgery: an observational study. Eur J Anaesthesiol. 2013 Aug;30(8):501-8. doi: 10.1097/EJA.0b013e3283603250.
PubMed 23549128Kaye AD, Vadivelu N, Ahuja N, Mitra S, Silasi D, Urman RD. Anesthetic considerations in robotic-assisted gynecologic surgery. Ochsner J. 2013 Winter;13(4):517-24.
PubMed 24358000Huang L, Critchley LA. An assessment of two Doppler-based monitors to track cardiac output changes in anaesthetised patients undergoing major surgery. Anaesth Intensive Care. 2014 Sep;42(5):631-9. doi: 10.1177/0310057X1404200514.
PubMed 25233178Argun G, Sahin MK. The impact of patient position changes on advanced hemodynamic indices in laparoscopic and open major abdominal cancer surgeries: retrospective study. BMC Surg. 2025 Aug 6;25(1):341. doi: 10.1186/s12893-025-03064-8.
PubMed 40770328
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient Position Changes on Advanced Hemodynamic Indices in Laparoscopic and Open Major Abdominal Cancer Surgeries
- ClinicalTrials.gov ID
- NCT06293391
- Acronym / sponsor ID
- 2022-11/2097
- Conditions
- Abdominal Cancer, Blood Pressure, Cardiac Indices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 5 Mar 2024 (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.
Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM.
Detailed description
Patients who underwent major abdominal cancer surgery using ODM in the operating room of our hospital between November 2021 and November 2022 were identified from the Anesthesiology Clinic records and examined according to whether they were operated with open or closed (laparoscopic) methods. Demographic data, vital signs, amount of bleeding, type and amount of fluid administered, and the results of cardiac index measurements performed with the ODM device in the supine and trendelenburg positions (45 degrees) were analyzed. Parameters recorded with the ODM device; CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ODM measurements of patients undergoing open surgery in supine and trendelenburg position | – | Procedure: cardiac indices in supine and trendelenburg positionAfter intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded. |
| ODM measurements of patients undergoing laparoscopic surgery in supine and trendelenburg position | – | Procedure: cardiac indices in supine and trendelenburg positionAfter intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study were intubated after standard anaesthesia induction with fentanyl 2 mcg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg, and ODM was used for case follow-up. All patients were followed with standard 6% desflurane anaesthetic gas and intravenous infusion of remifentanil, a short-acting opioid, after intubation. Mean arterial pressure was kept in the range of 65-80 mmHg in all patients, tidal volume was adjusted as 6-8 ml/kg, peep (positive end expiratory pressure) as 0-6 cm H2O and respiratory frequency as 10-15 /min for normocapnia. After intubation, intraoperative ODM measurements and intraoperative ODM measurements were retrospectively scanned and recorded in the supine and 45-degree angle trendelenburg position.
Key inclusion criteria (2 listed)
- Elective operation
- ASA 1-4
Key exclusion criteria (4 listed)
- Heart failure
- Valvular heart disease,
- Patients with symptomatic rhythm disturbances
- ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)
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 |
|---|---|---|
| cardiac indices in supine and trendelenburg positionCardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery | Procedure or surgery | ODM measurements of patients undergoing laparoscopic surgery in supine and trendelenburg position, ODM measurements of patients undergoing open surgery in supine and trendelenburg position |
Primary outcome
Cardiac Output
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Stroke Volume
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Flow time corrected
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Peak Velocity
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Stroke Distance
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Mean arterial pressure
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Pulse
Time frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
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 30 Apr 2026.
- Results publication: PubMed 28168868Heinink TP, Read DJ, Mitchell WK, Bhalla A, Lund JN, Phillips BE, Williams JP. Oesophageal Doppler guided optimization of cardiac output does not increase visceral microvascular blood flow in healthy volunteers. Clin Physiol Funct Imaging. 2018 Mar;38(2):213-219. doi: 10.1111/cpf.12401. Epub 2017 Feb 6.
- Results publication: PubMed 29208025Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.
- Results publication: PubMed 21815239Haas S, Haese A, Goetz AE, Kubitz JC. Haemodynamics and cardiac function during robotic-assisted laparoscopic prostatectomy in steep Trendelenburg position. Int J Med Robot. 2011 Dec;7(4):408-13. doi: 10.1002/rcs.410. Epub 2011 Aug 3.
- Results publication: PubMed 23549128Conway DH, Hussain OA, Gall I. A comparison of noninvasive bioreactance with oesophageal Doppler estimation of stroke volume during open abdominal surgery: an observational study. Eur J Anaesthesiol. 2013 Aug;30(8):501-8. doi: 10.1097/EJA.0b013e3283603250.
- Results publication: PubMed 24358000Kaye AD, Vadivelu N, Ahuja N, Mitra S, Silasi D, Urman RD. Anesthetic considerations in robotic-assisted gynecologic surgery. Ochsner J. 2013 Winter;13(4):517-24.
- Results publication: PubMed 25233178Huang L, Critchley LA. An assessment of two Doppler-based monitors to track cardiac output changes in anaesthetised patients undergoing major surgery. Anaesth Intensive Care. 2014 Sep;42(5):631-9. doi: 10.1177/0310057X1404200514.
- Derived from this study: PubMed 40770328Argun G, Sahin MK. The impact of patient position changes on advanced hemodynamic indices in laparoscopic and open major abdominal cancer surgeries: retrospective study. BMC Surg. 2025 Aug 6;25(1):341. doi: 10.1186/s12893-025-03064-8.
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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.
Mustafa Kemal SAHIN, M.D principal investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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 Abdominal Cancer and Blood Pressure, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 4 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 30 Apr 2026. 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 Output (time frame: Immediately after induction of anaesthesia and at any stable time during the case). The study lists 7 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 NCT06293391, which also lists 7 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 30 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.