Clinical trial NCT06861959: Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Laparoscopic Gynecologic Surgery
Peak Inspiratuar Pressure
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: peak inspiratory pressure (Ppeak) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
Secondary outcomes:
measure: Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Plateau Pressure (Pplateau) (cmH₂O) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Dynamic Lung Compliance (Cdyn) (mL/cmH₂O) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Respiratory Rate (RR) (breaths per minute) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Exhaled Tidal Volume (Exhale TV) (mL) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Hemodynamic parameters: Heart Rate (HR) (beats per minute) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) among the groups
timeFrame: 15 minutes after the induction, 30 minutes following CO₂ insufflation, 60 minutes after the initiation of pneumoperitoneum, 15 minutes after CO₂ deflation
measure: arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
timeFrame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
measure: arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups
timeFrame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
measure: arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups
timeFrame: 15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Children's Training and Research Hospital
state: Üsküdar
Study officials:
References:
citation: 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.