AzTrials
AzTrials

CholelithiasesVCV VS PCVNCT07709039

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

A study of Cholelithiases and Laparoscopic Cholecystectomy, run by Mehreen Mirza at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 50 years
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Jan 2026to 20 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Nishtar Medical University and Hospital, Multan

    Multan, Punjab Province, 00000

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
Volume-Controlled Ventilation, Pressure Controlled Ventilation
Keywords
Volume-Controlled Ventilation, Pressure-Controlled Ventilation, Mechanical Ventilation, Laparoscopic Cholecystectomy, Static Lung Compliance, End-Tidal Carbon Dioxide, Respiratory Mechanics, Pneumoperitoneum, General Anesthesia
Medical subject headings
Cholelithiasis, Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volume-Controlled VentilationProcedure or surgery

    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.

  • Pressure Controlled VentilationProcedure or surgery

    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.

Study groups in NCT07709039
Study groupRoleWhat they receive
Volume Controlled VentilationExperimentalParticipants receive volume-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia.
Receives: Procedure: Volume-Controlled Ventilation
Pressure Controlled VentilationExperimentalParticipants receive pressure-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia.
Receives: Procedure: Pressure Controlled Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Static Lung Compliance

    Comparison of static lung compliance between the volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) groups during elective laparoscopic cholecystectomy under general anesthesia.

    Measured: 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.

  2. End-Tidal Carbon Dioxide (EtCO₂)

    Comparison of end-tidal carbon dioxide (EtCO₂) levels between the VCV and PCV groups.

    Measured: 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.

Secondary outcomes (1)
  1. Peak Inspiratory Pressure

    Comparison of peak inspiratory pressure between the VCV and PCV groups during laparoscopic cholecystectomy.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start1 Jan 2026
  3. Primary completion30 Jun 2026
  4. Study completion20 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709039
Sponsor's protocol ID
18717 / NMU
Acronym
VCV VS PCV
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because no formal data-sharing plan has been established. Participant confidentiality and institutional ethical requirements will be maintained.

Questions about this trial

What is this clinical trial studying?

A study of Cholelithiases and Laparoscopic Cholecystectomy, run by Mehreen Mirza at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static Lung Compliance (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in