- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06293391
The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery
April 26, 2026 updated by: Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06200
- Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Elective operation
- ASA 1-4
Exclusion Criteria:
- Heart failure
- Valvular heart disease,
- Patients with symptomatic rhythm disturbances
- ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery
|
|
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.
|
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
|
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.
|
Immediately after induction of anaesthesia and at any stable time during the case
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mustafa Kemal SAHIN, M.D, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Yonis 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.
- Haas 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.
- Conway 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.
- Kaye 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.
- Huang 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.
- Argun 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
February 5, 2024
Study Registration Dates
First Submitted
February 15, 2024
First Submitted That Met QC Criteria
February 27, 2024
First Posted (Actual)
March 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 26, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-11/2097
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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