The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery

Blood Pressure Clinical Trial

Official title:

The Effect Of Patient Position Changes On Advanced Cardiac Indices In Laparoscopic And Open Major Abdominal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06293391
• Other study ID #: 2022-11/2097
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms
• Blood Pressure

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