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Recruiting NCT07550738

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

No phase Interventional PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis.
Who it may be relevant to
Registry conditions: PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (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. [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Egypt · 1 center
  • South Egypt cancer institute , Assiut university — Asyut

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. PMID 33991554
  • 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. PMID 17695343
  • 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. PMID 27687346
  • 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. PMID 28216699
  • 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. PMID 33808607
  • 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. PMID 20303833

Identifiers

NCT: NCT07550738 · Ventilation modes differences

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗