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

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Laparoscopic Gynecologic Surgery; Peak Inspiratuar Pressure

• Registration Number: NCT06861959
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-01
• Study First Submitted: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
peak inspiratory pressure (Ppeak) 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	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.

Secondary Outcome Measures

Name	Time	Method
arterial blood gas analysis: Arterial Partial Pressure of Oxygen (PaO₂) (mmHg) among the groups	15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum	Arterial Partial Pressure of Carbon Dioxide (PaCO₂) (mmHg); Arterial blood gas analysis was conducted at T1 and T3.
Hemodynamic parameters: Heart Rate (HR) (beats 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	Heart Rate (HR) (beats per minute); hemodynamic parameters were recorded at T1 to T4
Hemodynamic parameters:Mean Arterial Pressure (MAP) (mmHg) 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	Mean Arterial Pressure (MAP) (mmHg); hemodynamic parameters were recorded at T1 to T4
Hemodynamic parameters: Peripheral Oxygen Saturation (SpO₂) (%) 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	Peripheral Oxygen Saturation (SpO₂) (%); hemodynamic parameters were recorded at T1 to T4
Hemodynamic parameters:End-Tidal CO₂ (EtCO₂) (mmHg) 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	End-Tidal CO₂ (EtCO₂) (mmHg); hemodynamic parameters were recorded at T1 to T4
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	Mean Inspiratory Pressure (Pmean) (cmH₂O); Ventilation variables was recorded at T1 to T4.
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	Plateau Pressure (Pplateau) (cmH₂O); Ventilation variables was recorded at T1 to T4.
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	Dynamic Lung Compliance (Cdyn) (mL/cmH₂O); Ventilation variables was recorded at T1 to T4.
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	Respiratory Rate (RR) (breaths per minute); Ventilation variables was recorded at T1 to T4.
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	Exhaled Tidal Volume (Exhale TV) (mL); Ventilation variables was recorded at T1 to T4.
arterial blood gas analysis: Arterial Oxygen Saturation (SaO₂) (%) among the groups	15 minutes after the induction, 60 minutes after the initiation of pneumoperitoneum	Arterial Oxygen Saturation (SaO₂) (%); Arterial blood gas analysis was conducted at T1 and T3.

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Children's Training and Research Hospital; 🇹🇷 Istanbul, Üsküdar, Turkey