- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433530
Hemodynamic Effects of Mechanical Ventilation Strategies During Laparoscopic Nephrectomy
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sehitkamil
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Gaziantep, Sehitkamil, Turkey (Türkiye), 5327842151
- Elzem Sen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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? 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:
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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:
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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.
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Change in Cardiac Index
|
Measured after induction of anesthesia, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and after extubation.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elzem Sen, Assoc Prof, University of Gaziantep
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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