PCV-VG Versus VCV Ventilation Mode Effects on HemodynamicsNCT07550738
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
A study testing electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis in people with PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics
- What is being tested?
- electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt cancer institute , Assiut university
Asyut
Saif eldeen Gamal Khalaf, Assistant lecturer, +20-1033893202, saifeldeen616@gmail.com
About this study
Official title: 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.
- Being tested
- electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Volume controlled ventilation ( VCV ) | Experimental | Not described Receives: Diagnostic Test: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis |
| Pressure-controlled ventilation-volume guaranteed (PCV-VG) | Experimental | Not described Receives: Diagnostic Test: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PCV-VG Versus VCV Ventilation Mode Effects on HemodynamicsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- South Egypt Cancer Institute
- Responsible party
- Principal investigator, Saif Eldeen Gamal Khalaf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550738
- Sponsor's protocol ID
- Ventilation modes differences
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 33991554Faul 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.
PubMed 17695343Assad 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.
PubMed 27687346Jaju 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.
PubMed 28216699Schick 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.
PubMed 33808607Ogurlu 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.
PubMed 20303833Cote 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.
PubMed 24916144Rajaram 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.
PubMed 23450539Saugel 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.
PubMed 29621027De 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.
PubMed 29725695Patil S, Koyyalamudi P, Robertson C, et al. Physiologic effects of pneumoperitoneum and positioning. In: Kaye A, Urman R, editors. Perioperative management in robotic surgery.
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.
PubMed 29557671Ford 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.
PubMed 27828799
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07550738
- Acronym / sponsor ID
- Ventilation modes differences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- South Egypt Cancer Institute
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasiselectrical 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 | Diagnostic test | Pressure-controlled ventilation-volume guaranteed (PCV-VG), Volume controlled ventilation ( VCV ) |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- BackgroundBernstein DP, Osypka MJ (2003) Apparatus and method for determining an approximation of the stroke volume and the cardiac output of the heart. Google Patents.
- BackgroundOsypka M. An introduction to electrical cardiometry 2009; 49 1-10. Osypka Medical GmbH.
- Background: PubMed 33991554Yilmaz 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.
- Background: PubMed 17695343Faul 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.
- Background: PubMed 27687346Assad 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.
- Background: PubMed 28216699Jaju 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.
- Background: PubMed 33808607Schick 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.
- Background: PubMed 20303833Ogurlu 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.
- Background: PubMed 24916144Cote 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.
- Background: PubMed 23450539Rajaram 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.
- Background: PubMed 29621027Saugel 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.
- Background: PubMed 29725695De 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis in people with PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saif eldeen Gamal Khalaf, Assistant lecturer (+20-1033893202, saifeldeen616@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550738, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.