Clinical trial NCT06293391: The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery
Official title: The Impact of Patient Position Changes on Advanced Hemodynamic Indices in Laparoscopic and Open Major Abdominal Cancer Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Cancer
Blood Pressure
Cardiac Indices
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac Output
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Stroke Volume
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Flow time corrected
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Peak Velocity
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Stroke Distance
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Mean arterial pressure
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
measure: Pulse
timeFrame: Immediately after induction of anaesthesia and at any stable time during the case
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital
Study officials:
affiliation: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
name: Mustafa Kemal SAHIN, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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):213-219. doi: 10.1111/cpf.12401. Epub 2017 Feb 6.
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 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.
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.
citation: 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.
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.
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.