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Hemodynamic Effects of Mechanical Ventilation Strategies During Laparoscopic Nephrectomy

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07433530
Enrollment
30
Registered
2026-02-25
Start date
2025-04-08
Completion date
2025-11-07
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Nephrectomy

Brief summary

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.

Detailed description

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.

Interventions

? 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.

Sponsors

University of Gaziantep
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Due to the nature of the intervention, the anesthesiology team administering the ventilation strategy was aware of group allocation. Patients were under general anesthesia during the intervention. Advanced hemodynamic parameters were recorded objectively using the PRAM monitoring system. Therefore, the study was conducted as an open-label trial without masking.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Index (CI)Measured after induction of anesthesia, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and after extubation.Change in Cardiac Index

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORElzem Sen, Assoc Prof

University of Gaziantep

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026