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Идёт набор 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

Без фазы С лечением PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: electrical cardiometry ('ICON CARDIOTRONIC, OSYPKA MEDICAL') , Lung ultrasonography (LUS) for atelectasis.
Кому может быть актуально
Состояния в реестре: PCV-VG Versus VCV Ventilation Mode Effects on Hemodynamics. Базовые параметры: 20 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Диагностический тест 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)

Первичные конечные точки

  • 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. [Срок оценки: One year to one and half years]
Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: One and half years]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT07550738 · Ventilation modes differences

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗