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

NCT ID: NCT06861959

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-09-01

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.

Conditions

Mechanical Ventilation; Laparoscopic Gynecologic Surgery; Peak Inspiratuar Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group VCV

Patients in this group were ventilated using Volume-Controlled Ventilation (VCV) mode throughout the procedure.

Group Type: ACTIVE_COMPARATOR

Device: Volume-Controlled Ventilation (VCV)

Intervention Type: 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)

Group PCV

Patients in this group were ventilated using Pressure-Controlled Ventilation (PCV) mode throughout the procedure.

Group Type: ACTIVE_COMPARATOR

Device: Pressure-Controlled Ventilation (PCV)

Intervention Type: 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)

Group PCV-VG

Patients in this group were ventilated using Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG) mode throughout the procedure.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

kübra taşkın

anesthesiology and reanimation specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zeynep Kamil Maternity and Children's Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31836201 (View on PubMed)

Other Identifiers

keahanest

Identifier Type: -

Identifier Source: org_study_id