Anesthesia ComplicationNCT06245317
PCV-VG in Pediatric Laparoscopic Surgery
A study testing Mechanical Ventilation Mode in people with Anesthesia Complication and Mechanical Ventilation Complication, run by Assiut University at 1 site in Egypt.
Trial summary
This Study will aim to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Anesthesia Complication, Mechanical Ventilation Complication
- What is being tested?
- Mechanical Ventilation Mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Jan 2025
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-II.
- Both sexes.
- Age: 1-8 years old.
- Scheduled for elective abdominal or urologic laparoscopic surgery.
- BMI between the 5th and 95th percentiles.
Who cannot join
- ASA physical status more than II.
- Pre-existing lung disease.
- Pre-operative chest infection.
- Any thoracic deformities.
- Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level.
- Patients with cardiac, hepatic, or renal diseases.
- BMI above and below the 95th and 5th percentile respectively.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, Asyut Governorate
About this study
Official title: Effects of Pressure Controlled-volume Guarantee Ventilation on Respiratory Mechanics in Pediatric Laparoscopic Surgery
This Study will aim to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in pediatric laparoscopic surgery.
Read the detailed description
Laparoscopic surgery is superior to open surgery in terms of recovery time, less postoperative pain, less wound complications, shorter hospital stay, and earlier return to work. However, carbon dioxide insufflation causes several intraoperative cardiovascular, renal, and respiratory adverse effects. Regarding respiratory effects, elevated Intra-abdominal pressure and abdominal expansion shifts the diaphragm upwards. Thus, intrathoracic pressure increases, and expansion of the lungs is restricted. This is followed by a significant decrease up to 50% in pulmonary dynamic compliance and an increase in peak and plateau airway pressures. After deflation of pneumoperitoneum both the pulmonary compliance and airway pressures return to the baseline levels. High airway pressures and decreased compliance can be associated with pulmonary barotrauma, which may manifest as immediate pneumothorax. The basal lung regions are compressed during elevated IAP causing atelectasis and uneven ventilation-perfusion relationships, impairing gas exchange. Hence, the choice of ventilation mode is very important, especially in the paediatric population. Volume control ventilation (VCV) and pressure control ventilation (PCV) modes have been used but each has its own drawbacks, with the former risking increase in airway pressure when pulmonary compliance changes which can lead to barotrauma and the latter not guaranteeing the desired tidal volume which leads to hypoventilation that presents with hypercarbia. Pressure Control Ventilation - Volume Guarantee (PCV-VG) is a recent controlled ventilation mode that combines the benefits of both volume control ventilation (VCV) and pressure control ventilation (PCV) by delivering the preset tidal volume with a decelerating flow at the lowest possible peak inspiratory pressure during a preset inspiratory time and at a preset respiratory rate ensuring adequate ventilation .
- Being tested
- Mechanical Ventilation Mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Ventilation ModeDevice
Each arm will have a different ventilation mode according to the allocation.
| Study group | Role | What they receive |
|---|---|---|
| Pressure control ventilation-volume guarantee (PCV-VG) group | Active comparator | In the PCV-VG group the tidal volume will be set to 8-10ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO¬2. Receives: Device: Mechanical Ventilation Mode |
| Pressure control ventilation (PCV) group | Active comparator | In the PCV group peak inspiratory pressure will be set to 10-15 cm H2O titrated to achieve 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal Co2 Receives: Device: Mechanical Ventilation Mode |
| Volume control ventilation (VCV) group | Active comparator | In the VCV group tidal volume will be set to 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO2, Receives: Device: Mechanical Ventilation Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung dynamic compliance (Cdyn)
Dynamic compliance represents pulmonary compliance during periods of gas flow, such as during active inspiration.
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Secondary outcomes (7)
PaO2
The PaO2 partial pressure from arterial blood gas analysis will be recorded.
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
SpO2%
The peripheral arterial saturation will be recorded.
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
PaCO2
The PaCo2 partial pressure from arterial blood gas analysis will be recorded.
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
End-tidal CO2
The end-tidal CO2 will be recoded from the main stream capnography
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Mean airway pressure
The mean airway pressure will be recorded from the ventilator electronic display in the GE anesthesia machine
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Peak inspiratory pressure
The PIP will be recorded from the ventilator electronic display in the GE anesthesia machine
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Tidal volume
The exhaled tidal volume will be recorded from the ventilator electronic display in the GE anesthesia machine
Measured: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Feb 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in paediatrics laparoscopic surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Muhammed Mahmoud Khalil, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Study director, Assiut UniversityYara H Abbas, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245317
- Sponsor's protocol ID
- 04-2023-200588
- Status last verified
- Jul 2024
- First submitted
- 14 Jan 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Controlled-volume Guarantee Ventilation on Respiratory Mechanics in Pediatric Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06245317
- Acronym / sponsor ID
- 04-2023-200588
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Feb 2024 (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 will aim to compare the effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in pediatric laparoscopic surgery.
Detailed description
Laparoscopic surgery is superior to open surgery in terms of recovery time, less postoperative pain, less wound complications, shorter hospital stay, and earlier return to work. However, carbon dioxide insufflation causes several intraoperative cardiovascular, renal, and respiratory adverse effects. Regarding respiratory effects, elevated Intra-abdominal pressure and abdominal expansion shifts the diaphragm upwards. Thus, intrathoracic pressure increases, and expansion of the lungs is restricted. This is followed by a significant decrease up to 50% in pulmonary dynamic compliance and an increase in peak and plateau airway pressures. After deflation of pneumoperitoneum both the pulmonary compliance and airway pressures return to the baseline levels. High airway pressures and decreased compliance can be associated with pulmonary barotrauma, which may manifest as immediate pneumothorax. The basal lung regions are compressed during elevated IAP causing atelectasis and uneven ventilation-perfusion relationships, impairing gas exchange. Hence, the choice of ventilation mode is very important, especially in the paediatric population. Volume control ventilation (VCV) and pressure control ventilation (PCV) modes have been used but each has its own drawbacks, with the former risking increase in airway pressure when pulmonary compliance changes which can lead to barotrauma and the latter not guaranteeing the desired tidal volume which leads to hypoventilation that presents with hypercarbia. Pressure Control Ventilation - Volume Guarantee (PCV-VG) is a recent controlled ventilation mode that combines the benefits of both volume control ventilation (VCV) and pressure control ventilation (PCV) by delivering the preset tidal volume with a decelerating flow at the lowest possible peak inspiratory pressure during a preset inspiratory time and at a preset respiratory rate ensuring adequate ventilation .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- effects of Pressure Controlled Ventilation - Volume Guarantee (PCV-VG) mode with volume control ventilation (VCV) and pressure control ventilation (PCV) modes on respiratory mechanics (including the dynamic compliance, PIP, mean airway pressure, driving pressure..etc) and oxygenation in paediatrics laparoscopic surgery.
| Arm | Type | Receives |
|---|---|---|
| Pressure control ventilation-volume guarantee (PCV-VG) group | Active comparator | Device: Mechanical Ventilation ModeIn the PCV-VG group the tidal volume will be set to 8-10ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO¬2. |
| Pressure control ventilation (PCV) group | Active comparator | Device: Mechanical Ventilation ModeIn the PCV group peak inspiratory pressure will be set to 10-15 cm H2O titrated to achieve 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal Co2 |
| Volume control ventilation (VCV) group | Active comparator | Device: Mechanical Ventilation ModeIn the VCV group tidal volume will be set to 8-10 ml/kg and the respiratory rate will be adjusted according to oxygen saturation and end-tidal CO2, |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASA physical status I-II.
- Both sexes.
- Age: 1-8 years old.
- Scheduled for elective abdominal or urologic laparoscopic surgery.
- BMI between the 5th and 95th percentiles.
Key exclusion criteria (7 listed)
- ASA physical status more than II.
- Pre-existing lung disease.
- Pre-operative chest infection.
- Any thoracic deformities.
- Unsatisfactory pre-operative arterial oxygen saturation or haemoglobin level.
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 |
|---|---|---|
| Mechanical Ventilation ModeEach arm will have a different ventilation mode according to the allocation. | Device | Pressure control ventilation (PCV) group, Pressure control ventilation-volume guarantee (PCV-VG) group, Volume control ventilation (VCV) group |
Primary outcome
Lung dynamic compliance (Cdyn)
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Dynamic compliance represents pulmonary compliance during periods of gas flow, such as during active inspiration.
7 secondary outcomes
PaO2
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
SpO2%
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
PaCO2
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
End-tidal CO2
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Mean airway pressure
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Peak inspiratory pressure
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Tidal volume
Time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Hala S Abdel-Ghaffar, MD study director
Assiut University
Yara H Abbas, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Ventilation Mode in people with Anesthesia Complication and Mechanical Ventilation Complication, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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 Mahmoud M Khalil, MBBS (1068434214 ext. +20, mahmoud.muhammed1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung dynamic compliance (Cdyn) (time frame: 5 minutes after intubation (T1), 5 minutes after pneumoperitoneum (T2), 15 minutes after pneumoperitoneum (T3), 5 minutes after desufflation of pneumoperitoneum (T4) and 5 minutes after the operation (T5)). 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 30 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.