The Effects of VC Versus PC Ventilation on Cerebral and Respiratory Parameters in Patients Undergoing Laparoscopic Gynecologic Surgery

NCT06482983 | Recruiting

• 1 other identifier: UERH-AR-ZT-07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to determine whether the use of different mechanical ventilation modes in patients with Trendelenburg position and CO2 insufflation affects respiration and cerebral oxygenation due to postoperative atelectasis, and was to determine whether there was any hemodynamic effect.

Conditions

Anesthesia; Gynecologic Cancer; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

• pulmonary datas in laparoscopic gynecologic surgery.

  peak airway pressure (minumum 40 cm H2O ,maksimum 40 cm H2O)

  one week

• cerebral datas in laparoscopic gynecologic

  NIRS (20% change from baseline value)

  one week

Study Arms (3)

ventilation mode during surgery

ACTIVE COMPARATOR

Volume control mode (VC) n: 40

Procedure: Mechanical Ventilation Mode

Pressure-controlled volume guaranteed mode (PC-VG) ventilation

ACTIVE COMPARATOR

Pressure-controlled volume guaranteed mode (PC-VG) n:40

Procedure: Mechanical Ventilation Mode

Pressure control mode (PC) ventilation

ACTIVE COMPARATOR

Pressure control mode (PC) n:40

Procedure: Mechanical Ventilation Mode

Interventions

Mechanical Ventilation Mode PROCEDURE

after intubation different ventilation mode (VC,PC,PC-VG)

Also known as: Pressure-controlled volume guaranteed mode ventilation, Pressure control mode ventilation

Pressure control mode (PC) ventilation; Pressure-controlled volume guaranteed mode (PC-VG) ventilation; ventilation mode during surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age
• ASA 1-3

You may not qualify if:

• Under 18 years of age, over 70 years of age,
• ASA IV,
• history of severe chronic obstructive pulmonary disease (COPD, GOLD III or IV)
• ,-history of severe or uncontrolled bronchial asthma, presence of restrictive lung disease,
• history of any thoracic surgery operation, need for thoracic drainage before surgery
• patients receiving preoperative renal replacement therapy,
• congestive heart failure (NYHA grade III or IV),
• extremely obese (body Mass Index, BMI \> 35 Kg/m2)
• patients without patient consent

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye research and education hospital

Istanbul, Umraniye, 34764, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group I: Volume control mode (VC) n: 40 Group II: Pressure-controlled volume guaranteed mode (PC-VG) n:40 Group III: Pressure control mode (PC) n:40
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Reanimation department,Assoc Prof

Model Details: Group I: Volume control mode (VC) n: 40 Group II: Pressure-controlled volume guaranteed mode (PC-VG) n:40 Group III: Pressure control mode (PC) n:40

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: July 1, 2024
• Study Start: May 1, 2023
• Primary Completion: September 30, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

TU (1)