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Completed

NCT Number: NCT07433530

Hemodynamic Effects of Mechanical Ventilation Strategies During Laparoscopic Nephrectomy

Purpose: To compare hemodynamic effects of two different modes of ventilation (volume-controlled and pressure-controlled volume guaranteed) in patients undergoing laparoscopic gynecology surgeries with exaggerated Trendelenburg position.

Methods: Thirty patients undergoing laparoscopic gynecology operations were ventilated using either volume-controlled (Group VC) or pressure-controlled volume guaranteed mode (Group PCVG) (n = 15 for both groups). Hemodynamic variables were measured using Pressure Recording Analytical Method by radial artery cannulation in addition to peak and mean airway pressures and expired tidal volume.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elzem Sen

Gaziantep, Sehitkamil, 5327842151, Turkey (Türkiye)

About this study

Laparoscopic nephrectomy requires the creation of pneumoperitoneum and lateral positioning, both of which may significantly affect respiratory mechanics and cardiovascular function. Increased intra-abdominal pressure and elevated intrathoracic pressure during pneumoperitoneum may reduce venous return, alter ventricular loading conditions, and impair cardiac output. Therefore, intraoperative ventilatory strategy may play a critical role not only in pulmonary protection but also in maintaining hemodynamic stability.

Lung-protective ventilation (LPV), characterized by low tidal volume, moderate positive end-expiratory pressure (PEEP), and periodic recruitment maneuvers, has been shown to reduce ventilator-induced lung injury and postoperative pulmonary complications. However, its hemodynamic consequences during laparoscopic surgery under pneumoperitoneum remain controversial.

This prospective, randomized, controlled study was designed to compare the effects of lung-protective ventilation and standard ventilation strategies on advanced hemodynamic parameters in patients undergoing elective laparoscopic nephrectomy.

Thirty ASA I-III patients aged 18-70 years were randomized into two groups:

Group A (Lung-Protective Ventilation): Tidal volume 6 mL/kg, PEEP 5-8 cmH₂O, periodic recruitment maneuvers.

Group B (Standard Ventilation): Tidal volume 8-10 mL/kg, PEEP 0-2 cmH₂O. Advanced hemodynamic monitoring was performed using the PRAM (Pressure Recording Analytical Method) system via radial arterial catheterization. Parameters including cardiac index (CI), cardiac output (CO), stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PPV), systemic vascular resistance (SVR), arterial elastance (Ea), cardiac cycle efficiency (CCE), and cardiac power output (CPO) were recorded at seven predefined perioperative time points: before induction, after induction, after lateral positioning, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and post-extubation.

The primary outcome was the comparison of advanced hemodynamic parameters between ventilation strategies. Secondary outcomes included evaluation of hemodynamic responses to positional changes and pneumoperitoneum.

This study aims to clarify whether lung-protective ventilation provides hemodynamic advantages in addition to pulmonary protection during laparoscopic nephrectomy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 70 years

ASA physical status I-III

Scheduled for elective laparoscopic nephrectomy

Ability to provide written informed consent

Exclusion criteria

Emergency surgery

Hemodynamic instability

Severe cardiac disease (including significant valvular disease or uncontrolled arrhythmia)

Endocrine disorders affecting hemodynamic status

Hemoglobin < 10 g/dL

Known coagulation disorders

Ongoing anticoagulant therapy

Severe peripheral arterial disease

History of cerebrovascular accident

Pregnancy

Advanced hepatic failure

Advanced renal failure

Body mass index (BMI) > 35 kg/m²

Conversion from laparoscopic to open surgery

Inability to maintain arterial catheterization

Refusal to participate

Treatment and study plan

Lung Protective Ventilation

Procedure

? Intervention 1 Lung Protective Ventilation

Intervention Description:

Patients were ventilated using a lung-protective mechanical ventilation strategy with tidal volume of 6-8 mL/kg of ideal body weight, PEEP of 5-10 cmH₂O, plateau pressure <30 cmH₂O, and driving pressure <15 cmH₂O. Respiratory rate was adjusted to maintain PaCO₂ between 35-45 mmHg. Recruitment maneuvers (30-40 cmH₂O for 10-15 seconds) were applied when clinically indicated.? Intervention 2 Standard Ventilation

Intervention Description:

Patients were ventilated using a conventional mechanical ventilation strategy with tidal volume of 10-12 mL/kg of ideal body weight and PEEP of 0-2 cmH₂O. Respiratory rate was adjusted to maintain PaCO₂ between 35-45 mmHg.

Other names: Standart ventilation

Primary outcomes

  1. Cardiac Index (CI)

    Time frame: Measured after induction of anesthesia, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and after extubation.

    Change in Cardiac Index

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

A Comparative Evaluation of Mechanical Ventilation Strategies and Their Hemodynamic Effects During Laparoscopic Nephrectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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