Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position

Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation; Laparoscopic Gynecologic Surgery; Peak Inspiratuar Pressure
• Intervention / Treatment: Device: Device: Volume-Controlled Ventilation (VCV); Device: Device: Pressure-Controlled Ventilation (PCV); Device: Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey
      • Zeynep Kamil Maternity and Children's Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The study included patients aged 20-65 years
• Classified as American Society of Anesthesiologists (ASA) physical status I or III
• who were scheduled to undergo an elective laparoscopic gynecologic surgery with pneumoperitoneum lasting at least one hour in the steep Trendelenburg position.

Exclusion Criteria:

• morbid obesity (BMI > 40 kg/m²)
• pulmonary or cardiac diseases (e.g., chronic obstructive pulmonary disease, heart failure)
• a history of difficult intubation
• Patients requiring conversion to laparotomy or experiencing hemodynamic instability during surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group VCV; Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure.	Device: Device: Volume-Controlled Ventilation (VCV); 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)
Active Comparator: Group PCV; Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure.	Device: Device: Pressure-Controlled Ventilation (PCV); 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)
Active Comparator: Group PCV-VG; 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); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups	Mean Inspiratory Pressure (Pmean) (cmH₂O) Ventilation variables was recorded at T1 to T4.	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.	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.	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.	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.	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	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	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	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	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.	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.	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.	15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

General Publications

• Toker MK, Altiparmak B, Uysal AI, Demirbilek SG. [Comparison of pressure-controlled volume-guaranteed ventilation and volume-controlled ventilation in obese patients during gynecologic laparoscopic surgery in the Trendelenburg position]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):553-560. doi: 10.1016/j.bjan.2019.09.003. Epub 2019 Dec 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: keahanest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No