Hemodynamic Effects of Mechanical Ventilation Strategies During Laparoscopic Nephrectomy

February 21, 2026 updated by: Elzem SEN, University of Gaziantep

A Comparative Evaluation of Mechanical Ventilation Strategies and Their Hemodynamic Effects 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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey (Türkiye), 5327842151
        • Elzem Sen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung Protective Ventilation
Patients in this group received lung-protective ventilation consisting of a tidal volume of 6 mL/kg predicted body weight, positive end-expiratory pressure (PEEP) of 5-8 cmH₂O, and periodic recruitment maneuvers performed every 30 minutes during surgery.

? 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
Active Comparator: Standard Ventilation
Patients in this group received conventional mechanical ventilation with a tidal volume of 8-10 mL/kg predicted body weight and low PEEP (0-2 cmH₂O) without routine recruitment maneuvers.

? 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured after induction of anesthesia, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and after extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elzem Sen, Assoc Prof, University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Actual)

November 6, 2025

Study Completion (Actual)

November 7, 2025

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HRÜ/25.08.36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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