Volume-Controlled VentilationNCT06117748
Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery
A study of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Volume-Controlled Ventilation, Pressure-Controlled Ventilation Volume Guaranteed, Obese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2023to 1 Jul 2024
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 16 - 60 years old.
- Sex: both males and females.
- Undergoing elective Laparoscopic Surgery.
- Obese patient with Body Mass Index between ≥30 Kg/m2.
- American society of Anesthesiologist (ASA) class I/ II.
Who cannot join
- Patient refusal.
- American society of Anesthesiology (ASA) III or IV.
- Intraoperative hemodynamic instability.
- Patients with pulmonary hypertension.
- Obese patients on home O2 therapy
- Pneumoperitoneum with CO2 with intra-abdominal pressure exceeding 15mmHg.
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- Anti-Trendelenburg position.
- Asthmatic Patients.
- Patients with advanced liver disease.
- Patients with advanced renal disease.
- Patients with advanced malignancy.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Ahmed M Soliman, Master, 00201066556377, ahmedmaamounmaamoun2013@gmail.com
Mohamed I El Seidy, MD
About this study
Official title: Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery
The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position.
Read the detailed description
Obesity, defined as a Body Mass Index (BMI) >30 kg.m-2", is characterized by increased airway resistance, labored breathing and decreased respiratory system compliance. An increased rate of obese patients undergoing laparoscopic assisted surgery (LAS) is a health care concern due to anesthesia and ventilation difficulties in the obese population. Therefore, understanding the physiology and pathophysiology of lung function is an important issue during long-lasting LAS.
Carbon dioxide pneumoperitoneum with steep Trendelenburg positioning leads to a cranial displacement of the diaphragm and an increased volume of atelectasis, with a consequent decrease of total lung volume, lung compliance, and functional residual capacity. Thus, alleviation of increased airway pressure, improvement in oxygenation and CO2 elimination are the main goals during anesthetic management in laparoscopic assisted surgery.
In pressure controlled ventilation volume-guaranteed (PCV-VG) mode, the ventilator regulates the Peak Inspiratory Pressure (PIP) to achieve the optimal TV. To achieve the target volume, ventilator parameters are regularly changed without adjusting airway pressures. Hence, PCV-VG has the advantages of both Volume-Controlled Ventilation (VCV) and pressure controlled ventilation (PCV) to preserve the target minute ventilation while maintaining a low incidence of barotraumas.
PCV-VG is a type-controlled ventilation mode with a dual character as it has the criteria of both PCV and VCV. This recent ventilation mode which is one of the pressure regulated volume controlled (PRVC) that include Auto Flow ventilation, offers the ability to reduce the inspiratory pressure and as a result the incidence of barotrauma
- Conditions
- Volume-Controlled Ventilation, Pressure-Controlled Ventilation Volume Guaranteed, Obese, Laparoscopy
- Being tested
- Pressure controlled ventilation-volume guaranteed, Volume controlled ventilation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure controlled ventilation-volume guaranteedOther
Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.
Respiratory parameters will be kept constant if ETCO2 is <45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.
Volume controlled ventilationOther
Respiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2.
Respiratory parameters will be kept constant if ETCO2 is <45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Group (PCV-VG): Pressure controlled ventilation-volume guaranteed | Experimental | Patients will receive pressure controlled ventilation-volume guaranteed Receives: Other: Pressure controlled ventilation-volume guaranteed |
| Group (VCV): Volume controlled ventilation | Other | Patients will receive Volume controlled ventilation Receives: Other: Volume controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Oxygenation index =mean airway pressure × fraction of inspired oxygen (FiO2) × 100÷ Partial pressure of oxygen (PaO2)
Measured: Till the end of surgery
Secondary outcomes (5)
Mean arterial blood pressure
Mean arterial blood pressure (MAP) will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.
Measured: Till the end of surgery
Heart rate
Heart rate (HR) will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.
Measured: Till the end of surgery
Oxygen saturation SpO2
Oxygen saturation SpO2 will be monitored 10 minutes before anesthesia induction , immediately before onset of pneumoperitoneum, every 10 minutes in the first hour, and at the end of surgery.
Measured: Till the end of surgery
Arterial PCo2
Arterial blood gases will be analyzed using a blood gas analyzer before anesthesia induction and every 10 minutes in the first hour for arterial oxygen tension (paO2) , arterial CO2 tension (paCO2).
Measured: Till the end of surgery
Lung compliance
Lung mechanics readings included peak air way pressure (Ppeak), plateau pressure (Pplat), mean airway pressure (Pmean), dynamic and static compliance of the respiratory system will be recorded after intubation and every 10 minutes in the first hour
Measured: Till the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 Nov 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume-Controlled 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maamoun Maamoun Soliman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117748
- Sponsor's protocol ID
- MD 280 / 2022
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effect of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic Assisted Surgery
- ClinicalTrials.gov ID
- NCT06117748
- Acronym / sponsor ID
- MD 280 / 2022
- Conditions
- Volume-Controlled Ventilation, Pressure-Controlled Ventilation Volume Guaranteed, Obese, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
The aim of this study is to compare the efficacy of the pressure controlled ventilation volume-guaranteed (PCV-VG) versus volume-controlled ventilation (VCV) modes as regards lung compliance and oxygenation index in obese patients undergoing laparoscopic assisted surgery especially in Trendelenburg position.
Detailed description
Obesity, defined as a Body Mass Index (BMI) >30 kg.m-2", is characterized by increased airway resistance, labored breathing and decreased respiratory system compliance. An increased rate of obese patients undergoing laparoscopic assisted surgery (LAS) is a health care concern due to anesthesia and ventilation difficulties in the obese population. Therefore, understanding the physiology and pathophysiology of lung function is an important issue during long-lasting LAS.
Carbon dioxide pneumoperitoneum with steep Trendelenburg positioning leads to a cranial displacement of the diaphragm and an increased volume of atelectasis, with a consequent decrease of total lung volume, lung compliance, and functional residual capacity. Thus, alleviation of increased airway pressure, improvement in oxygenation and CO2 elimination are the main goals during anesthetic management in laparoscopic assisted surgery.
In pressure controlled ventilation volume-guaranteed (PCV-VG) mode, the ventilator regulates the Peak Inspiratory Pressure (PIP) to achieve the optimal TV. To achieve the target volume, ventilator parameters are regularly changed without adjusting airway pressures. Hence, PCV-VG has the advantages of both Volume-Controlled Ventilation (VCV) and pressure controlled ventilation (PCV) to preserve the target minute ventilation while maintaining a low incidence of barotraumas.
PCV-VG is a type-controlled ventilation mode with a dual character as it has the criteria of both PCV and VCV. This recent ventilation mode which is one of the pressure regulated volume controlled (PRVC) that include Auto Flow ventilation, offers the ability to reduce the inspiratory pressure and as a result the incidence of barotrauma
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (PCV-VG): Pressure controlled ventilation-volume guaranteed | Experimental | Other: Pressure controlled ventilation-volume guaranteedPatients will receive pressure controlled ventilation-volume guaranteed |
| Group (VCV): Volume controlled ventilation | Other | Other: Volume controlled ventilationPatients will receive Volume controlled ventilation |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: 16 - 60 years old.
- Sex: both males and females.
- Undergoing elective Laparoscopic Surgery.
- Obese patient with Body Mass Index between ≥30 Kg/m2.
- American society of Anesthesiologist (ASA) class I/ II.
Key exclusion criteria (12 listed)
- Patient refusal.
- American society of Anesthesiology (ASA) III or IV.
- Intraoperative hemodynamic instability.
- Patients with pulmonary hypertension.
- Obese patients on home O2 therapy
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 |
|---|---|---|
| Pressure controlled ventilation-volume guaranteedRespiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2. Respiratory parameters will be kept constant if ETCO2 is <45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg. | Other | Group (PCV-VG): Pressure controlled ventilation-volume guaranteed |
| Volume controlled ventilationRespiratory parameters will be set as: actual tidal volume 8 mL/kg actual body weight, respiratory rate 12 breaths/min, PEEP of five mmHg, oxygen flow 1 L/min, fraction inspired oxygen (FiO2) 0.6, and I:E ratio of 1:2. Respiratory parameters will be kept constant if ETCO2 is <45 mmHg. When ETCO2 exceed 45 mmHg, respiratory rate or tidal volume will be adjusted to maintain ETCO2 below 45 mmHg. | Other | Group (VCV): Volume controlled ventilation |
Primary outcome
Oxygenation index
Time frame: Till the end of surgery
Oxygenation index =mean airway pressure × fraction of inspired oxygen (FiO2) × 100÷ Partial pressure of oxygen (PaO2)
5 secondary outcomes
Mean arterial blood pressure
Time frame: Till the end of surgery
Heart rate
Time frame: Till the end of surgery
Oxygen saturation SpO2
Time frame: Till the end of surgery
Arterial PCo2
Time frame: Till the end of surgery
Lung compliance
Time frame: Till the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed, run by Ain Shams University at 1 site in Egypt.
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 12 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Soliman, Master (00201066556377, ahmedmaamounmaamoun2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (time frame: Till the end of surgery). 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 7 Nov 2023.