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

NCT06861959 | Completed

• 1 other identifier: keahanest
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• peak inspiratory pressure (Ppeak) among the groups

  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.

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

Secondary Outcomes (12)

• Mean Inspiratory Pressure (Pmean) (cmH₂O) among the groups

  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) among the groups

  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) among the groups

  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) among the groups

  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) among the groups

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

Study Arms (3)

Group VCV

ACTIVE COMPARATOR

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

Device: Device: Volume-Controlled Ventilation (VCV)

Group PCV

ACTIVE COMPARATOR

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

Device: Device: Pressure-Controlled Ventilation (PCV)

Group PCV-VG

ACTIVE COMPARATOR

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

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

Interventions

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)

Group VCV

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)

Group PCV

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)

Group PCV-VG

Eligibility Criteria

• Age: 20 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Zeynep Kamil Maternity and Children's Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31836201 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist doctor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)