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
July 1, 2026 updated by: Saif Eldeen Gamal Khalaf, Assiut University
Effect of Pressure-Controlled Volume Guaranteed Versus Volume-Controlled Ventilation Modes on Hemodynamic Outcomes and Respiratory Mechanics During Laparoscopic Abdominal Cancer Surgeries With Exaggerated Trendelenberg Postion : A Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saif eldeen Gamal Khalaf, Assistant lecturer
- Phone Number: +20-1033893202
- Email: saifeldeen616@gmail.com
Study Locations
-
-
-
Asyut, Egypt
- Recruiting
- South Egypt cancer institute , Assiut university
-
Contact:
- Saif eldeen Gamal Khalaf, Assistant lecturer
- Phone Number: +20-1033893202
- Email: saifeldeen616@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
1 - 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
Exclusion Criteria:
1 - 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Volume controlled ventilation ( VCV )
|
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
|
|
Experimental: Pressure-controlled ventilation-volume guaranteed (PCV-VG)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: One year to one and half years
|
One year to one and half years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the respiratory effects effects including atelectasis development of two different modes of ventilation ( VCV and PC-VG ) during laparoscopic abdominal cancer surgeries.
Time Frame: One to two years
|
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.
Time Frame: One and half years
|
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.
Time Frame: One and half years
|
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.
Time Frame: One and half years
|
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.
Time Frame: One and half years
|
One and half years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Rouby JJ, Arbelot C, Gao Y, Zhang M, Lv J, An Y, Chunyao W, Bin D, Valente Barbas CS, Dexheimer Neto FL, Prior Caltabeloti F, Lima E, Cebey A, Perbet S, Constantin JM; APECHO Study Group. Training for Lung Ultrasound Score Measurement in Critically Ill Patients. Am J Respir Crit Care Med. 2018 Aug 1;198(3):398-401. doi: 10.1164/rccm.201802-0227LE. No abstract available.
- Assad OM, El Sayed AA, Khalil MA. Comparison of volume-controlled ventilation and pressure-controlled ventilation volume guaranteed during laparoscopic surgery in Trendelenburg position. J Clin Anesth. 2016 Nov;34:55-61. doi: 10.1016/j.jclinane.2016.03.053. Epub 2016 May 2.
- Ogurlu M, Kucuk M, Bilgin F, Sizlan A, Yanarates O, Eksert S, Karasahin E, Cosar A. Pressure-controlled vs volume-controlled ventilation during laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2010 May-Jun;17(3):295-300. doi: 10.1016/j.jmig.2009.10.007. Epub 2010 Mar 19.
- Ford JW, Heiberg J, Brennan AP, Royse CF, Canty DJ, El-Ansary D, Royse AG. A Pilot Assessment of 3 Point-of-Care Strategies for Diagnosis of Perioperative Lung Pathology. Anesth Analg. 2017 Mar;124(3):734-742. doi: 10.1213/ANE.0000000000001726.
- Schick V, Dusse F, Eckardt R, Kerkhoff S, Commotio S, Hinkelbein J, Mathes A. Comparison of Volume-Guaranteed or -Targeted, Pressure-Controlled Ventilation with Volume-Controlled Ventilation during Elective Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Mar 19;10(6):1276. doi: 10.3390/jcm10061276.
- De Backer D, Bakker J, Cecconi M, Hajjar L, Liu DW, Lobo S, Monnet X, Morelli A, Myatra SN, Perel A, Pinsky MR, Saugel B, Teboul JL, Vieillard-Baron A, Vincent JL. Alternatives to the Swan-Ganz catheter. Intensive Care Med. 2018 Jun;44(6):730-741. doi: 10.1007/s00134-018-5187-8. Epub 2018 May 3.
- Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, 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 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
- 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.
- Osypka M. An introduction to electrical cardiometry 2009; 49 1-10. Osypka Medical GmbH.
- 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.
- Yilmaz H, Kazbek BK, Koksoy UC, Gul AM, Ekmekci P, Caglar GS, Tuzuner 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. doi: 10.1016/j.bjane.2021.04.028. Epub 2021 May 12.
- Jaju R, Jaju PB, Dubey M, Mohammad S, Bhargava AK. Comparison of volume controlled ventilation and pressure controlled ventilation in patients undergoing robot-assisted pelvic surgeries: An open-label trial. Indian J Anaesth. 2017 Jan;61(1):17-23. doi: 10.4103/0019-5049.198406.
- Cote CJ, Sui J, Anderson TA, Bhattacharya ST, Shank ES, Tuason PM, August DA, Zibaitis A, Firth PG, Fuzaylov G, Leeman MR, Mai CL, Roberts JD Jr. Continuous noninvasive cardiac output in children: is this the next generation of operating room monitors? Initial experience in 402 pediatric patients. Paediatr Anaesth. 2015 Feb;25(2):150-9. doi: 10.1111/pan.12441. Epub 2014 Jun 10.
- Rajaram SS, Desai NK, Kalra A, Gajera M, Cavanaugh SK, Brampton W, Young D, Harvey S, Rowan K. Pulmonary artery catheters for adult patients in intensive care. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD003408. doi: 10.1002/14651858.CD003408.pub3.
- Saugel B, Vincent JL. Cardiac output monitoring: how to choose the optimal method for the individual patient. Curr Opin Crit Care. 2018 Jun;24(3):165-172. doi: 10.1097/MCC.0000000000000492.
- Arvizo C, Mehta ST, Yunker A. Adverse events related to Trendelenburg position during laparoscopic surgery: recommendations and review of the literature. Curr Opin Obstet Gynecol. 2018 Aug;30(4):272-278. doi: 10.1097/GCO.0000000000000471.
- St John A, Caturegli I, Kubicki NS, Kavic SM. The Rise of Minimally Invasive Surgery: 16 Year Analysis of the Progressive Replacement of Open Surgery with Laparoscopy. JSLS. 2020 Oct-Dec;24(4):e2020.00076. doi: 10.4293/JSLS.2020.00076.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
February 8, 2026
First Submitted That Met QC Criteria
April 22, 2026
First Posted (Actual)
April 24, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Ventilation modes differences
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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