Skip to main content
OpenTrials
Completed

NCT Number: NCT06861959

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mechanical Ventilation Laparoscopic Gynecologic Surgery Peak Inspiratuar Pressure

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Maternity and Children's Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Volume-Controlled Ventilation (VCV)

Device

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)

Device: Pressure-Controlled Ventilation (PCV)

Device

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)

Device: Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)

Device

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)

Primary outcomes

  1. peak inspiratory pressure (Ppeak) among the groups

    Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation

    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.

Secondary outcomes

  1. Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups

    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)

    Ventilation variables was recorded at T1 to T4.

  2. Plateau Pressure (Pplateau) (cmH₂O) among the groups

    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)

    Ventilation variables was recorded at T1 to T4.

  3. Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups

    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)

    Ventilation variables was recorded at T1 to T4.

  4. Respiratory Rate (RR) (breaths per minute) among the groups

    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)

    Ventilation variables was recorded at T1 to T4.

  5. Exhaled Tidal Volume (Exhale TV) (mL) among the groups

    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)

    Ventilation variables was recorded at T1 to T4.

  6. Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups

    Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation

    Heart Rate (HR) (beats per minute)

    hemodynamic parameters were recorded at T1 to T4

  7. Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups

    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 Arterial Pressure (MAP) (mmHg)

    hemodynamic parameters were recorded at T1 to T4

  8. Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups

    Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation

    Peripheral Oxygen Saturation (SpO₂) (%)

    hemodynamic parameters were recorded at T1 to T4

  9. Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups

    Time frame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation

    End-Tidal CO₂ (EtCO₂) (mmHg)

    hemodynamic parameters were recorded at T1 to T4

  10. arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups

    Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum

    Arterial Partial Pressure of Oxygen (PaO₂) (mmHg)

    Arterial blood gas analysis was conducted at T1 and T3.

  11. arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups

    Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum

    Arterial Partial Pressure of Carbon Dioxide (PaCO₂) (mmHg)

    Arterial blood gas analysis was conducted at T1 and T3.

  12. arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups

    Time frame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum

    Arterial Oxygen Saturation (SaO₂) (%)

    Arterial blood gas analysis was conducted at T1 and T3.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.