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"Comparison of of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Modes in Laparoscopic Cholecystectomy"

"Comparison of the Effects of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Modes on Compliance and End-Tidal CO2 In Patients Undergoing Laparoscopic Cholecystectomy"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07709039
Acronym
VCV VS PCV
Enrollment
60
Registered
2026-07-16
Start date
2026-01-01
Completion date
2026-07-20
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiases, General Anaesthesia, Laparoscopic Cholecystectomy

Keywords

Volume-Controlled Ventilation, Pressure-Controlled Ventilation, Mechanical Ventilation, Laparoscopic Cholecystectomy, Static Lung Compliance, End-Tidal Carbon Dioxide, Respiratory Mechanics, Pneumoperitoneum, General Anesthesia

Brief summary

This randomized controlled trial compares volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The study evaluates the effects of both ventilation modes on static lung compliance and end-tidal carbon dioxide (EtCO₂) at predefined intraoperative time points. The objective is to determine whether pressure-controlled ventilation provides improved respiratory mechanics and more effective ventilation compared with volume-controlled ventilation during laparoscopic surgery.

Detailed description

Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures under general anesthesia. Creation of carbon dioxide pneumoperitoneum during laparoscopic surgery increases intra-abdominal pressure, resulting in reduced functional residual capacity, decreased lung compliance, increased airway pressures, and alterations in carbon dioxide elimination. These physiological changes may impair respiratory mechanics and increase the risk of perioperative pulmonary complications. Therefore, selection of an appropriate mechanical ventilation strategy is essential to maintain adequate ventilation and optimize respiratory function during laparoscopic surgery. The objective of this randomized controlled trial is to compare the effects of volume-controlled ventilation and pressure-controlled ventilation on static lung compliance and end-tidal carbon dioxide (EtCO₂) in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The study aims to determine whether pressure-controlled ventilation provides superior intraoperative respiratory mechanics compared with volume-controlled ventilation while maintaining adequate ventilation throughout the surgical procedure. This is a prospective, single-center, randomized controlled trial conducted in the Department of Anaesthesia, Nishtar Hospital, Multan. A total of 60 adult patients aged 25-50 years, of either sex, classified as American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective laparoscopic cholecystectomy, will be enrolled after obtaining written informed consent. Patients with uncontrolled cardiopulmonary disease, diabetes mellitus, significant renal or hepatic impairment, chronic systemic illness, body mass index below 18.5 kg/m² or above 24.9 kg/m², or recent respiratory tract infection within the preceding three weeks will be excluded. Participants will be allocated in a 1:1 ratio using computer-generated randomization by an independent third party into one of two study groups. Group A will receive volume-controlled ventilation, while Group B will receive pressure-controlled ventilation. Allocation concealment will be maintained until initiation of mechanical ventilation. Baseline demographic variables including age, sex, and body mass index will be recorded before induction of anesthesia. A standardized anesthetic technique will be used for all participants. Mechanical ventilation settings will include a tidal volume of 8 mL/kg (with inspiratory pressure adjusted in the PCV group to achieve the target tidal volume), respiratory rate initially set at 12 breaths per minute and subsequently adjusted to maintain an end-tidal carbon dioxide concentration between 32 and 38 mmHg, inspiratory-to-expiratory ratio of 1:2, fraction of inspired oxygen (FiO₂) of 0.40, positive end-expiratory pressure (PEEP) of 5 cmH₂O, and oxygen saturation maintained above 95%. Carbon dioxide pneumoperitoneum will be maintained with an intra-abdominal pressure of 12-15 mmHg throughout the procedure. Static lung compliance and end-tidal carbon dioxide will be recorded at three predefined intraoperative time points: five minutes after induction of anesthesia, fifteen minutes after carbon dioxide insufflation in the reverse Trendelenburg position, and ten minutes after carbon dioxide desufflation. Measurements will be recorded using the integrated monitoring systems of the anesthesia workstation by a trained anesthesiologist who is not involved in group allocation. Blinding of the anesthesia provider is not feasible because of the nature of the interventions; however, the primary outcome measures are objective monitor-derived variables, minimizing the risk of measurement bias. The primary outcome measures are static lung compliance and end-tidal carbon dioxide measured at the predefined intraoperative time points. Data will be analyzed using SPSS version 26. Continuous variables will be summarized as mean ± standard deviation or median with interquartile range according to data distribution, while categorical variables will be expressed as frequencies and percentages. Between-group comparisons will be performed using the independent t-test or Mann-Whitney U test as appropriate, with stratification for age, sex, and body mass index where indicated. This study is expected to provide evidence regarding the optimal ventilation strategy during laparoscopic cholecystectomy and may contribute to improved intraoperative respiratory management and enhanced patient safety in routine anesthetic practice.

Interventions

Mechanical ventilation delivered using the volume-controlled ventilation mode during elective laparoscopic cholecystectomy under general anesthesia. Ventilation is provided with a tidal volume of 8 mL/kg, respiratory rate adjusted to maintain end-tidal carbon dioxide between 32 and 38 mmHg, PEEP of 5 cmH₂O, FiO₂ of 0.40, and an inspiratory-to-expiratory ratio of 1:2 throughout the surgical procedure.

Mechanical ventilation delivered using the pressure-controlled ventilation mode during elective laparoscopic cholecystectomy under general anesthesia. Inspiratory pressure is adjusted to achieve a tidal volume of 8 mL/kg while maintaining end-tidal carbon dioxide between 32 and 38 mmHg, with PEEP of 5 cmH₂O, FiO₂ of 0.40, and an inspiratory-to-expiratory ratio of 1:2 throughout the surgical procedure.

Sponsors

Mehreen Mirza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants are unaware of the assigned ventilation mode. Outcome measurements are objective monitor-derived parameters recorded using the anesthesia workstation, minimizing measurement bias. Care providers are not blinded because of the nature of the intervention.

Intervention model description

Participants are randomly assigned in a 1:1 ratio to receive either volume-controlled ventilation (VCV) or pressure-controlled ventilation (PCV) during elective laparoscopic cholecystectomy. Respiratory mechanics and end-tidal carbon dioxide are compared between the two parallel groups.

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients aged 25-50 years. * Either sex. * ASA physical status I or II. * Scheduled for elective laparoscopic cholecystectomy under general anaesthesia. * Written informed consent obtained.

Exclusion criteria

* ASA physical status III or IV. * Body mass index (BMI) greater than 35 kg/m². * Significant pulmonary disease (e.g., COPD, asthma, restrictive lung disease). * Significant cardiovascular disease. * Pregnancy. * Previous upper abdominal surgery. * Conversion to open cholecystectomy. * Refusal to participate.

Design outcomes

Primary

MeasureTime frameDescription
Static Lung ComplianceMeasured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.Comparison of static lung compliance between the volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) groups during elective laparoscopic cholecystectomy under general anesthesia.
End-Tidal Carbon Dioxide (EtCO₂)Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.Comparison of end-tidal carbon dioxide (EtCO₂) levels between the VCV and PCV groups.

Secondary

MeasureTime frameDescription
Peak Inspiratory PressureMeasured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.Comparison of peak inspiratory pressure between the VCV and PCV groups during laparoscopic cholecystectomy.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026