NCT06293391

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

28 days

First QC Date

February 15, 2024

Last Update Submit

April 26, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    Immediately after induction of anaesthesia and at any stable time during the case

Study Arms (2)

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.

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.

Procedure: cardiac indices in supine and trendelenburg position

Interventions

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 positionODM measurements of patients undergoing open surgery in supine and trendelenburg position

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Elective operation
  • ASA 1-4

You may not qualify if:

  • Heart failure
  • Valvular heart disease,
  • Patients with symptomatic rhythm disturbances
  • ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

MeSH Terms

Interventions

Supine PositionHead-Down Tilt

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mustafa Kemal SAHIN, M.D

    Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 5, 2024

Study Start

February 1, 2023

Primary Completion

March 1, 2023

Study Completion

February 5, 2024

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations