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.
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
- Conditions the study is for
- Cholelithiases, Laparoscopic Cholecystectomy, General Anaesthesia
- 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
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 group | Role | What they receive |
|---|---|---|
| Volume Controlled Ventilation | Experimental | Participants receive volume-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia. Receives: Procedure: Volume-Controlled Ventilation |
| Pressure Controlled Ventilation | Experimental | Participants 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.
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.
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)
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.
- First posted16 Jul 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mehreen Mirza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehreen Mirza, Nishtar Medical University
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT07709039
- Acronym / sponsor ID
- VCV VS PCV / 18717 / NMU
- Keywords
- Volume-Controlled Ventilation, Pressure-Controlled Ventilation, Mechanical Ventilation, Laparoscopic Cholecystectomy, Static Lung Compliance, End-Tidal Carbon Dioxide, Respiratory Mechanics, Pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mehreen MirzaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Volume Controlled Ventilation | Experimental | Procedure: Volume-Controlled VentilationParticipants receive volume-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia. |
| Pressure Controlled Ventilation | Experimental | Procedure: Pressure Controlled VentilationParticipants receive pressure-controlled ventilation during elective laparoscopic cholecystectomy under general anesthesia. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-Controlled VentilationMechanical 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. | Procedure or surgery | Volume Controlled Ventilation |
| Pressure Controlled VentilationMechanical 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. | Procedure or surgery | Pressure Controlled Ventilation |
Primary outcome
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.
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)
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.
Comparison of end-tidal carbon dioxide (EtCO₂) levels between the VCV and PCV groups.
1 secondary outcome
Peak Inspiratory Pressure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Cholelithiases
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.