Hemodynamic Effects of Mechanical Ventilation Strategies During Laparoscopic Nephrectomy

NCT07433530 | Completed

• 1 other identifier: HRÜ/25.08.36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Cardiac Index (CI)

  Change in Cardiac Index

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

Study Arms (2)

Lung Protective Ventilation

EXPERIMENTAL

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.

Procedure: Lung Protective Ventilation

Standard Ventilation

ACTIVE COMPARATOR

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.

Procedure: Lung Protective Ventilation

Interventions

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.

Also known as: Standart ventilation

Lung Protective Ventilation; Standard Ventilation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• ASA physical status I-III
• Scheduled for elective laparoscopic nephrectomy
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Elzem Sen

Gaziantep, Sehitkamil, 5327842151, Turkey (Türkiye)

Location

Study Officials

• Elzem Sen, Assoc Prof

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 25, 2026
• Study Start: April 8, 2025
• Primary Completion: November 6, 2025
• Study Completion: November 7, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

TU (1)