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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06293391
Other study ID # 2022-11/2097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 5, 2024

Study information

Verified date February 2024
Source Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 5, 2024
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
cardiac indices in supine and trendelenburg position
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery

Locations

Country Name City State
Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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 — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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 wi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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