Intraoperative VentilationNCT07543939
Peak Airway Pressure and Respiratory Mechanics During PRVC Ventilation in Laparoscopic Surgery
An observational study of Intraoperative Ventilation and Respiratory Mechanics, run by Specialized Medical Center (SMC) at 1 site in Saudi Arabia.
Trial summary
This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraoperative Ventilation, Respiratory Mechanics
- What is being tested?
- PRVC Ventilation
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Aug 2026to 29 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
Who may be able to join
- Adult patients aged 18-65 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- ASA physical status I-II
- Patients requiring mechanical ventilation using PRVC mode
- Provided informed consent
Who cannot join
- Patients with significant cardiopulmonary disease
- Chronic obstructive pulmonary disease or restrictive lung disease
- Morbid obesity (BMI > 35 kg/m²)
- Pregnancy
- Emergency surgeries
- Patients with anticipated difficult airway
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study
This study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.
The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.
Read the detailed description
Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.
Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.
This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, plateau pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at three predefined stages, each after a minimum 5-minute stabilization interval: after induction and intubation (supine, before pneumoperitoneum), after establishment of pneumoperitoneum, and after final surgical positioning.
The primary outcome will be the change in peak airway pressure across the three stages. Secondary outcomes include dynamic compliance and other ventilatory and hemodynamic parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.
- Conditions
- Intraoperative Ventilation, Respiratory Mechanics
- Being tested
- PRVC Ventilation
- Keywords
- PRVC ventilation, Laparoscopic surgery, Peak airway pressure, Dynamic compliance, General anesthesia, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRVC VentilationOther
Mechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced.
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort | Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points. Receives: Other: PRVC Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Airway Pressure
Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings.
Measured: At 0, 5, and 10 minutes intraoperatively
Secondary outcomes (8)
Dynamic Compliance
Dynamic lung compliance (Cdyn) measured intraoperatively using standard anesthesia monitoring at predefined time points.
Measured: At 0, 5, and 10 minutes intraoperatively
Plateau Pressure
Plateau pressure (Pplat) measured during controlled ventilation using the anesthesia workstation.
Measured: At 0, 5, and 10 minutes intraoperatively
End-tidal Carbon Dioxide
End-tidal carbon dioxide (EtCO2) measured continuously during mechanical ventilation.
Measured: At 0, 5, and 10 minutes intraoperatively
Mean Airway Pressure
Mean airway pressure measured intraoperatively using the anesthesia workstation.
Measured: At 0, 5, and 10 minutes intraoperatively
Oxygen Saturation
Peripheral oxygen saturation (SpO2) monitored continuously during surgery.
Measured: At 0, 5, and 10 minutes intraoperatively
Heart Rate (beats/min)
Heart rate measured intraoperatively using standard monitoring
Measured: At 0, 5, and 10 minutes intraoperatively
Mean Arterial Pressure (mmHg)
Mean arterial pressure measured intraoperatively using standard monitoring
Measured: At 0, 5, and 10 minutes intraoperatively
Minute Ventilation
Minute ventilation recorded from the anesthesia workstation during controlled ventilation.
Measured: At 0, 5, and 10 minutes intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start8 Aug 2026
- Primary completion29 Oct 2026
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Specialized Medical Center (SMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salaheldin A Abdelaziz Ahmed, MD, Principal investigator, Specialized Medical Center (SMC), Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543939
- Sponsor's protocol ID
- IRB-002-2026
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Airway Pressure and Respiratory Mechanics During Pressure-Regulated Volume Control Ventilation in Patients Undergoing Laparoscopic Abdominal Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07543939
- Acronym / sponsor ID
- IRB-002-2026
- Conditions
- Intraoperative Ventilation, Respiratory Mechanics
- Keywords
- PRVC ventilation, Laparoscopic surgery, Peak airway pressure, Dynamic compliance, General anesthesia, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Specialized Medical Center (SMC)University, hospital or other
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- 29 Oct 2026 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 22 Apr 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 study aims to evaluate peak airway pressure and respiratory mechanics during pressure-regulated volume control (PRVC) ventilation in patients undergoing elective laparoscopic abdominal surgery. Pneumoperitoneum and patient positioning during laparoscopic procedures can significantly affect respiratory mechanics, including airway pressures and lung compliance.
The study will assess changes in peak airway pressure, dynamic compliance, and other ventilatory parameters during different intraoperative phases. The findings are expected to provide insights into optimizing ventilatory strategies to improve patient safety and minimize ventilator-associated complications during laparoscopic surgery.
Detailed description
Laparoscopic abdominal surgery requires the creation of pneumoperitoneum, which increases intra-abdominal pressure and affects respiratory system mechanics. These changes can lead to increased peak airway pressure and reduced lung compliance, potentially increasing the risk of ventilator-induced lung injury.
Pressure-regulated volume control (PRVC) ventilation is designed to deliver a set tidal volume with the lowest possible airway pressure by adjusting inspiratory pressure dynamically. However, its performance during laparoscopic procedures and its effect on respiratory mechanics require further evaluation.
This prospective observational study will be conducted on adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Standardized anesthesia and ventilation protocols will be applied. Respiratory parameters including peak airway pressure, plateau pressure, tidal volume, respiratory rate, and dynamic compliance will be recorded at three predefined stages, each after a minimum 5-minute stabilization interval: after induction and intubation (supine, before pneumoperitoneum), after establishment of pneumoperitoneum, and after final surgical positioning.
The primary outcome will be the change in peak airway pressure across the three stages. Secondary outcomes include dynamic compliance and other ventilatory and hemodynamic parameters. The study aims to enhance understanding of respiratory mechanics during PRVC ventilation and support evidence-based optimization of intraoperative ventilation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort | – | Other: PRVC VentilationAdult patients undergoing elective laparoscopic abdominal surgery under general anesthesia with pressure-regulated volume control (PRVC) ventilation. Respiratory parameters are recorded at predefined intraoperative time points. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center.
Key inclusion criteria (5 listed)
- Adult patients aged 18-65 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- ASA physical status I-II
- Patients requiring mechanical ventilation using PRVC mode
- Provided informed consent
Key exclusion criteria (7 listed)
- Patients with significant cardiopulmonary disease
- Chronic obstructive pulmonary disease or restrictive lung disease
- Morbid obesity (BMI > 35 kg/m²)
- Pregnancy
- Emergency surgeries
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 |
|---|---|---|
| PRVC VentilationMechanical ventilation using pressure-regulated volume control mode applied as part of routine intraoperative anesthesia care. No experimental intervention is introduced. | Other | Single Cohort |
Primary outcome
Peak Airway Pressure
Time frame: At 0, 5, and 10 minutes intraoperatively
Peak airway pressure (PIP) measured intraoperatively using the anesthesia workstation under standardized pressure-regulated volume control ventilation settings.
8 secondary outcomes
Dynamic Compliance
Time frame: At 0, 5, and 10 minutes intraoperatively
Plateau Pressure
Time frame: At 0, 5, and 10 minutes intraoperatively
End-tidal Carbon Dioxide
Time frame: At 0, 5, and 10 minutes intraoperatively
Mean Airway Pressure
Time frame: At 0, 5, and 10 minutes intraoperatively
Oxygen Saturation
Time frame: At 0, 5, and 10 minutes intraoperatively
Heart Rate (beats/min)
Time frame: At 0, 5, and 10 minutes intraoperatively
Mean Arterial Pressure (mmHg)
Time frame: At 0, 5, and 10 minutes intraoperatively
Minute Ventilation
Time frame: At 0, 5, and 10 minutes intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. No, individual participant data (IPD) will not be shared.
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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.
Salaheldin A Abdelaziz Ahmed, MD principal investigator
Specialized Medical Center (SMC), Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Ventilation and Respiratory Mechanics, run by Specialized Medical Center (SMC) at 1 site in Saudi Arabia.
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 7 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: finished, as of the sponsor's last update on 3 Nov 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Airway Pressure (time frame: At 0, 5, and 10 minutes intraoperatively). 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 3 Nov 2026.