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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

R

Republic of Turkey Ministry of Health

Status

Completed

Conditions

Laparoscopic Gynecologic Surgery
Mechanical Ventilation
Peak Inspiratuar Pressure

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06861959
keahanest

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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