An interventional study of Device: Volume-Controlled Ventilation (VCV) and Device: Pressure-Controlled Ventilation (PCV) in Mechanical Ventilation, Laparoscopic Gynecologic Surgery and Peak Inspiratuar Pressure, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Other
Objective:
This study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in the steep Trendelenburg position. The hypothesis was that PCV and PCV-VG would be superior to VCV in optimizing respiratory mechanics and improving oxygenation, particularly by reducing peak inspiratory pressure (Ppeak).
Methods:
Prospective, randomized, controlled clinical trial. Sixty ASA I-III patients aged 20-65 years undergoing elective laparoscopic gynecologic surgery in the steep Trendelenburg position were included (20 patients per ventilation group).
Patients were randomized into VCV, PCV, and PCV-VG groups. Intraoperative ventilation was performed with a tidal volume of 8 mL/kg, PEEP of 5 cmH2O, and intra-abdominal pressure maintained at 12-14 mmHg.
Data were collected at four time points: T1 (after induction, supine), T2 (30 min after CO2 insufflation, Trendelenburg), T3 (60 min after pneumoperitoneum), and T4 (after CO2 deflation, supine).
Primary outcome: Ppeak comparison between groups. Secondary outcomes: Dynamic lung compliance (Cdyn), mean inspiratory pressure (Pmean), gas exchange, and hemodynamic parameters.
Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 76 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure.
Device: Device: Volume-Controlled Ventilation (VCV)
Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure.
Device: Device: Pressure-Controlled Ventilation (PCV)
Patients in this group were ventilated using Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) mode throughout the procedure.
Device: Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)
Tidal volume: 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
Initial peak inspiratory pressure adjusted to deliver a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
Pressure-controlled mode with volume guarantee to maintain a tidal volume of 8 mL/kg of ideal body weight Respiratory rate adjusted to maintain an end-tidal CO₂ (EtCO₂) level of 30-35 mmHg Inspiratory-expiratory ratio: 1:2 PEEP: 5 cmH₂O Mechanical ventilation was provided using a Datex-Ohmeda Avance Anesthesia Machine (GE Healthcare, USA) Measurements were taken at four predefined time points (T1-T4)
peak inspiratory pressure (Ppeak) among the groups
The primary outcome of the study was to compare peak inspiratory pressure (Ppeak) (cmH₂O) among the VCV, PCV, and PCV-VG ventilation modes in patients undergoing laparoscopic gynecologic surgery in the steep Trendelenburg position. Data were collected at four predefined time points during the study. The first time point (T1) was measured 15 minutes after the induction of anesthesia, with patients in the supine position. The second time point (T2) was recorded 30 minutes following CO₂ insufflation and positioning in the Trendelenburg position. The third time point (T3) represented measurements taken 60 minutes after the initiation of pneumoperitoneum. The final time point (T4) was assessed 15 minutes after CO₂ deflation and the return of patients to the supine position.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups
Mean Inspiratory Pressure (Pmean) (cmH₂O) Ventilation variables was recorded at T1 to T4.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Plateau Pressure (Pplateau) (cmH₂O) among the groups
Plateau Pressure (Pplateau) (cmH₂O) Ventilation variables was recorded at T1 to T4.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) Ventilation variables was recorded at T1 to T4.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Respiratory Rate (RR) (breaths per minute) among the groups
Respiratory Rate (RR) (breaths per minute) Ventilation variables was recorded at T1 to T4.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Exhaled Tidal Volume (Exhale TV) (mL) among the groups
Exhaled Tidal Volume (Exhale TV) (mL) Ventilation variables was recorded at T1 to T4.
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups
Heart Rate (HR) (beats per minute) hemodynamic parameters were recorded at T1 to T4
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups
Mean Arterial Pressure (MAP) (mmHg) hemodynamic parameters were recorded at T1 to T4
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups
Peripheral Oxygen Saturation (SpO₂) (%) hemodynamic parameters were recorded at T1 to T4
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups
End-Tidal CO₂ (EtCO₂) (mmHg) hemodynamic parameters were recorded at T1 to T4
Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) Arterial blood gas analysis was conducted at T1 and T3.
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
Arterial Partial Pressure of Carbon Dioxide (PaCO₂) (mmHg) Arterial blood gas analysis was conducted at T1 and T3.
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups
Arterial Oxygen Saturation (SaO₂) (%) Arterial blood gas analysis was conducted at T1 and T3.
Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
Plan to share: Yes
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Dr. Lutfi Kirdar Kartal Training and Research Hospital