Effect of Pressure-Controlled Volume Guaranteed Versus Volume-Controlled Ventilation Modes on Hemodynamic Outcomes e.g ( SV, CO ) and Respiratory Mechanics During Laparoscopic Abdominal Cancer Surgeries With Exaggerated Trendelenberg Postion

NCT07550738 | Not Yet Recruiting DMC

• 1 other identifier: Ventilation modes differences
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome is to compare the hemodynamic outcomes ( e.g SV , CO and CI ) using The ICON of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries with exaggerated trendelenburg position. And the secondary outcomes is to compare the respiratory effects ( e.g atelectasis development , plateau pressure(Pplat) , peak inspiratory pressure(PIP) , dyn. compliance and postoperative inflammatory indicators e.g CRP and WBCs ) of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries with exaggerated trendelenburg position.

Conditions

PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Is to compare the hemodynamic outcomes mainly cardiac output ( CO) using The ICON of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One year to one and half years

Secondary Outcomes (5)

• To compare the respiratory effects effects including atelectasis development of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One to two years

• To compare the respiratory effects including dynamic compliance of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One and half years

• To compare the respiratory effects including plateau pressure (Pplat) of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One and half years

• To compare the respiratory effects including peak inspiratory pressure ( PIP) of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One and half years

• To compare postoperative inflammatory indicators e.g CRP , WBCs of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.

  One and half years

Study Arms (2)

Volume controlled ventilation ( VCV )

EXPERIMENTAL

Diagnostic Test: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis

Pressure-controlled ventilation-volume guaranteed (PCV-VG)

EXPERIMENTAL

Diagnostic Test: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis

Interventions

electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis DIAGNOSTIC_TEST

electrical cardiometry estimates cardiac parameters by measuring changes in thoracic electrical bioimpedance during the cardiac cycle. The ICON, using four electrocardiogram (ECG) electrodes, estimates the maximum rate of change of impedance to peak aortic blood acceleration based on the principle that red blood cells change from random orientation during diastole (high impedance) to an aligned state during systole (low impedance). This device estimates CO, cardiac index (CI), stroke volume (SV), systemic vascular resistance (SVR), and a variety of other cardiac parameters ... Lung ultrasonography (LUS) in patients who are under anesthesia and scheduled for surgery can detect intraoperative atelectasis, and the LUS score is correlated with perioperative oxygenation impairment

Pressure-controlled ventilation-volume guaranteed (PCV-VG); Volume controlled ventilation ( VCV )

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who will be scheduled for elective laparoscopic abdominal cancer surgeries 2- patients aged 20-80 years 3- patients have an American Society of Anesthesiologists (ASA) physical status I-II

You may not qualify if:

• Patients with severe systemic disease (history of myocardial infarction, chronic obstructive, or restrictive lung disease) 2- Obese patients (BMI \> 30) 3- patients with neurologic or neuromuscular diseases.

Sponsors & Collaborators

• Assiut University: lead
• South Egypt Cancer Institute: collaborator

Study Sites (1)

South Egypt cancer institute , Assiut university

Asyut, Egypt

Location

Related Publications (18)

• Bernstein DP, Osypka MJ (2003) Apparatus and method for determining an approximation of the stroke volume and the cardiac output of the heart. Google Patents.

  BACKGROUND

• Osypka M. An introduction to electrical cardiometry 2009; 49 1-10. Osypka Medical GmbH.

  BACKGROUND

• 16. Yılmaz H, Kazbek BK, Köksoy ÜC, Gül AM, Ekmekçi P, Çağlar GS, Tüzüner F. Hemodynamic outcome of different ventilation modes in laparoscopic surgery with exaggerated trendelenburg: a randomised controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):88-94.

  BACKGROUND

• 15. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.

  BACKGROUND

• Assad, O.M.; El Sayed, A.A.; Khalil, M.A. Comparison of volume-controlled ventilation and pressure-controlled ventilation volume guaranteed during laparoscopic surgery in Trendelenburg position. J. Clin. Anesth. 2016, 34, 55-61.

  BACKGROUND

• 13. Jaju, R.; Jaju, P.B.; Dubey, M.; Mohammad, S.; Bhargava, A.K. Comparison of volume controlled ventilation and pressure controlled ventilation in patients undergoing robot-assisted pelvic surgeries: An open-label trial. Indian J. Anaesth. 2017, 61, 17-23.

  BACKGROUND

• 12. Schick V, Dusse F, Eckardt R, Kerkhoff S, Commotio S, Hinkelbein J, Mathes A. Comparison of Volume-Guaranteed or -Targeted, PressureControlled Ventilation with Volume-Controlled Ventilation during Elective Surgery: A Systematic Review and Meta-Analysis. J Clin Med 2021; 10 [PMID: 33808607 DOI: 10.3390/jcm10061276]

  BACKGROUND

• 11. O˘gurlu M, Küc¸ük M, Bilgin F, et al. Pressure-controlled vs volume-controlled ventilation during laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2010;17:295---300.

  BACKGROUND

• 10. Coté CJ, Sui J, Anderson TA, Bhattacharya ST, Shank ES, Tuason PM, et al. Continuous noninvasive cardiac output in children: is this the next generation of operating room monitors? Initial experience in 402 pediatric patients. Pediatr Anesth 2015; 25:150-159.

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• Rajaram SS, Desai NK, Kalra A, Gajera M, Cavanaugh SK, et al. Pulmonary artery catheters for adult patients in intensive care. Cochrane Database Syst Rev. 2013.

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• Saugel B, Vincent JL. Cardiac output monitoring: how to choose the optimal method for the individual patient. Curr Opin Crit Care. 2018;24(3):165-72.

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• De Backer D, Bakker J, Cecconi M, Hajjar L, Liu DW, et al. Alternatives to the Swan-Ganz catheter. Intensive Care Med. 2018;44(6):730-41.

  BACKGROUND

• Patil S, Koyyalamudi P, Robertson C, et al. Physiologic effects of pneumoperitoneum and positioning. In: Kaye A, Urman R, editors. Perioperative management in robotic surgery.

  BACKGROUND

• Rouby, J.-J.; Arbelot, C.; Gao, Y.; Zhang, M.; Lv, J.; An, Y.; Chunyao, W.; Bin, D.; Barbas, C.S.V.; Neto, F.L.D.; et al. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am. J. Respir. Crit. Care Med. 2018, 1198, 398-401.

  BACKGROUND

• Ford, J.W.; Heiberg, J.; Brennan, A.P.; Royse, C.F.; Canty, D.J.; El-Ansary, D.; Royse, A.G. A Pilot Assessment of 3 Point-of-Care Strategies for Diagnosis of Perioperative Lung Pathology.

  BACKGROUND

• Canet, J.; Sabaté, S.; Mazo, V.; Gallart, L.; de Abreu, M.G.; Belda, J.; Langeron, O.; Hoeft, A.; Pelosi, P.; PERISCOPE Group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur. J. Anaesthesiol. 2015, 32, 458-470

  BACKGROUND

• Arvizo C, Mehta S, Yunker A. Adverse events related to Trendelenburg position during laparoscopic surgery: recommendations and review of the literature. Curr Opin Obstet Gynecol. 2018;30:272-8

  BACKGROUND

• John AS, Caturegli I, Kubicki NS, Kavic SM. The rise of minimally invasive surgery: 16 year analysis of the progressive replacement of open surgery with l'aparoscopy.

  BACKGROUND

Related Links

• Related Info

Central Study Contacts

Saif eldeen Gamal Khalaf, Assistant lecturer

CONTACT

+20-1033893202; saifeldeen616@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-01

Locations

EG (1)