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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06861959
Enrollment
60
Registered
2025-03-06
Start date
2021-01-01
Completion date
2021-09-01
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecologic Surgery, Mechanical Ventilation, Peak Inspiratuar Pressure

Brief summary

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.

Interventions

DEVICEDevice: 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)

DEVICEDevice: 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)

DEVICEDevice: 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)

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
peak inspiratory pressure (Ppeak) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationThe 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

MeasureTime frameDescription
Plateau Pressure (Pplateau) (cmH₂O) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationPlateau Pressure (Pplateau) (cmH₂O) Ventilation variables was recorded at T1 to T4.
Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationDynamic Lung Compliance (Cdyn) (mL/cmH₂O) Ventilation variables was recorded at T1 to T4.
Respiratory Rate (RR) (breaths per minute) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationRespiratory Rate (RR) (breaths per minute) Ventilation variables was recorded at T1 to T4.
Exhaled Tidal Volume (Exhale TV) (mL) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationExhaled Tidal Volume (Exhale TV) (mL) Ventilation variables was recorded at T1 to T4.
Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationHeart Rate (HR) (beats per minute) hemodynamic parameters were recorded at T1 to T4
Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationMean Inspiratory Pressure (Pmean) (cmH₂O) Ventilation variables was recorded at T1 to T4.
Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationPeripheral Oxygen Saturation (SpO₂) (%) hemodynamic parameters were recorded at T1 to T4
Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationEnd-Tidal CO₂ (EtCO₂) (mmHg) hemodynamic parameters were recorded at T1 to T4
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneumArterial Partial Pressure of Oxygen (PaO₂) (mmHg) Arterial blood gas analysis was conducted at T1 and T3.
arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneumArterial Oxygen Saturation (SaO₂) (%) Arterial blood gas analysis was conducted at T1 and T3.
Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflationMean Arterial Pressure (MAP) (mmHg) hemodynamic parameters were recorded at T1 to T4

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026