AtelectasisVentiEIT_pedNCT07182539
VCV vs PRVC in Pediatric Anesthesia; an EIT- and LS-based Study
A study testing PRVC ventilation and VCV ventilation in people with Atelectasis, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
The primary objective of this study is to evaluate and compare the incidence and severity of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) and EIT (Electrical Impedance Tomography), between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- PRVC ventilation and VCV ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2025to Jan 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients requiring intraoperative mechanical ventilation via endotracheal intubation
- Written informed consent obtained from parents or legal guardians. For children capable of understanding, assent will also be obtained based on age and cognitive ability.
- ASA (American Society of Anesthesiologists) physical status I-II
Who cannot join
- Patients with significant pre-existing lung disease (e.g., cystic fibrosis, severe bronchopulmonary dysplasia, severe uncontrolled asthma, neuromuscular disease with respiratory compromise).
- Patients with complex congenital heart disease or significant hemodynamic instability.
- Patients undergoing thoracic surgery or procedures that could significantly alter lung mechanics (e.g., pre-existing pneumothorax).
- Refusal of parents/guardians or patient to participate in the study.
- History of previous intrathoracic procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Vittore Buzzi Children's Hospital
Milan
Anna Camporesi, M.D., +393355793744, anna.camporesi@asst-fbf-sacco.it
About this study
Official title: Atelectasis in Pediatric Anesthesia: A Randomized Observational Study Comparing Volume-Controlled and Pressure-Regulated Volume Control Ventilation Via Lung Ultrasound and Electrical Impedance Tomography
The primary objective of this study is to evaluate and compare the incidence and severity of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) and EIT (Electrical Impedance Tomography), between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG)
Read the detailed description
Background Mechanical ventilation is often required in pediatric anesthesia. However, the optimal intraoperative ventilatory strategy for pediatric patients remains a matter of debate, with no definitive consensus to date. Among conventional modes, Pressure-Controlled Ventilation (PCV) is time-triggered, pressure-limited, time cycled; set parameters include peak inspiratory pressure (PIP), inspiratory time (Ti) and respiratory rate (RR). Tidal Volume (TV) is a dependent variable. With the constant pressure throughout inspiration, PCV is thought to provide the maximum inspiratory pressure for the entire inspiratory-time favoring lung recruitment1.
In contrast, Volume-Controlled ventilation (VCV) delivers the preset TV, and the PIP is dependent on the respiratory mechanics of the patient. VCV has the advantage of certain TV delivery, while PCV has the advantage of not exceeding the set PIP1.
Both have limitations and to overcome the inherent compromises of traditional modes, modern ventilation modes such as Pressure Regulated Volume Control (PRVC) have been developed. These modes are designed to combine the benefits of VCV and PCV. They use a pressure-controlled flow and ventilation application approach, integrated with digital feedback mechanisms that continuously monitor the applied tidal volume, targeting a fixed tidal volume. PRVC allows the ventilator to measure the patient's lung compliance on a breath-to-breath basis and determine the pressure required to be given for the set Ti to achieve the set tidal volume. As a result, the ventilator can deliver a square wave pressure waveform like PCV but also ensure that a constant tidal volume is delivered to the patient like VCV.
Regardless of the ventilation strategy, general anesthesia inevitably induces atelectasis2, due to different mechanisms such as: shift of the diaphragm towards the thorax thus causing compressions of some lung areas, surfactant alteration due to inhalational anaesthetics, high inspired fractions of oxygen (FiO2) which are reabsorbed from the alveoli into the bloodstream causing reduction of the alveolar size3. These effects are demonstrable both immediately after induction and at the endo of surgery.
Children are particularly vulnerable to anaesthesia-induced atelectasis, due to the relatively higher compliant chest wall and the presence of diaphragmatic compression by large abdominal organs4. The clinical consequences of atelectasis are significant and include increased intrapulmonary shunt (blood passing through the lungs without being oxygenated), perioperative desaturation, higher risk of pneumonia, and a broader spectrum of postoperative pulmonary complications (PPCs)5. Given the peculiarities that predispose paediatric patients to atelectasis, they cannot be considered simply as miniature adults; their unique physiology requires tailored protective ventilation strategies. This highlights the urgency of identifying optimal ventilatory modes capable of minimizing atelectasis in this vulnerable population Since the best ventilatory strategy to avoid atelectasis is not defined currently, with the present randomized clinical trial the investigators aim to compare the effects of two ventilatory modes (VCV and PRVC) at same settings in terms of tidal volume, PEEP, FiO2, on atelectasis as described by lung ultrasound and EIT. The investigators hypnotized that PRVC (combining pressure control with guaranteed tidal volume) reduces atelectasis severity compared to VCV, as measured by LUS and EIT.
- Conditions
- Atelectasis
- Being tested
- PRVC ventilation, VCV ventilation
- Keywords
- Atelectasis, Lung Ultrasound, EIT, Pediatric Anesthesia
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRVC ventilationOther
Ventilation in PRVC mode.
VCV ventilationOther
Ventilation in VCV mode.
| Study group | Role | What they receive |
|---|---|---|
| PRVC ventilation | Experimental | Patients in this arm will be ventilated in PRVC. Receives: Other: PRVC ventilation |
| VCV ventilation | Active comparator | Patients in this arm will be ventilated in VCV. Receives: Other: VCV ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis at lung ultrasound
To compare the incidence of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) , between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG).
Measured: From baseline to recovery in post-anesthesia care unit
Atelectasis
To compare the severity of intraoperative pulmonary atelectasis, measured by EIT, between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG).
Measured: From baseline to recovery in post-anesthesia care unit
Secondary outcomes (5)
Regional distribution of ventilation and lung homogeneity
Compare regional distribution of ventilation between VCV and PRVC groups. This will be accomplished using parameters derived from Thoracic Electrical Impedance (EIT), such as Global Inhomogeneity Index (GI) and center of ventilation (CoV).
Measured: From baseline to recovery in post-anesthesia care unit
Peak Inspiratory Pressure
Evaluate the impact of the two ventilation modes on Peak Inspiratory Pressure (PIP).
Measured: From baseline to recovery in post-anesthesia care unit
Plateau Pressure
Evaluate the impact of the two ventilation modes on Plateau Pressure.
Measured: From baseline to recovery in post-anesthesia care unit
Static Respiratory System Compliance
Evaluate the impact of the two ventilation modes on Static respiratory System Compliance
Measured: From baseline to recovery in post-anesthesia care unit
Dynamic Respiratory System Compliance
Evaluate the impact of the two ventilation modes on Dynamic respiratory System Compliance
Measured: From baseline to recovery in post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies 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
- Randomization: Eligible patients will be randomized in an equal manner (1:1) to receive Volume Control Ventilation (VCV) or Pressure Regulated Volume Control (PRVC/PCV-VG). The randomization sequence will be generated by a computerized system to ensure unpredictability of the assignment. Randomization will be managed by an independent investigator not involved in direct patient care or data collection and will be stratified by center.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Camporesi, Vittore Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182539
- Sponsor's protocol ID
- VentiEIT_ped
- Acronym
- VentiEIT_ped
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x.
PubMed 39369249Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021.
PubMed 11511953Kim YS, Won YJ, Lee DK, Lim BG, Kim H, Lee IO, Yun JH, Kong MH. Lung ultrasound score-based perioperative assessment of pressure-controlled ventilation-volume guaranteed or volume-controlled ventilation in geriatrics: a prospective randomized controlled trial. Clin Interv Aging. 2019 Jul 18;14:1319-1329. doi: 10.2147/CIA.S212334. eCollection 2019.
PubMed 31409981Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.
PubMed 31351452
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atelectasis in Pediatric Anesthesia: A Randomized Observational Study Comparing Volume-Controlled and Pressure-Regulated Volume Control Ventilation Via Lung Ultrasound and Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT07182539
- Acronym / sponsor ID
- VentiEIT_ped / VentiEIT_ped
- Conditions
- Atelectasis
- Keywords
- Atelectasis, Lung Ultrasound, EIT, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Sep 2025 (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 primary objective of this study is to evaluate and compare the incidence and severity of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) and EIT (Electrical Impedance Tomography), between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG)
Detailed description
Background Mechanical ventilation is often required in pediatric anesthesia. However, the optimal intraoperative ventilatory strategy for pediatric patients remains a matter of debate, with no definitive consensus to date. Among conventional modes, Pressure-Controlled Ventilation (PCV) is time-triggered, pressure-limited, time cycled; set parameters include peak inspiratory pressure (PIP), inspiratory time (Ti) and respiratory rate (RR). Tidal Volume (TV) is a dependent variable. With the constant pressure throughout inspiration, PCV is thought to provide the maximum inspiratory pressure for the entire inspiratory-time favoring lung recruitment1.
In contrast, Volume-Controlled ventilation (VCV) delivers the preset TV, and the PIP is dependent on the respiratory mechanics of the patient. VCV has the advantage of certain TV delivery, while PCV has the advantage of not exceeding the set PIP1.
Both have limitations and to overcome the inherent compromises of traditional modes, modern ventilation modes such as Pressure Regulated Volume Control (PRVC) have been developed. These modes are designed to combine the benefits of VCV and PCV. They use a pressure-controlled flow and ventilation application approach, integrated with digital feedback mechanisms that continuously monitor the applied tidal volume, targeting a fixed tidal volume. PRVC allows the ventilator to measure the patient's lung compliance on a breath-to-breath basis and determine the pressure required to be given for the set Ti to achieve the set tidal volume. As a result, the ventilator can deliver a square wave pressure waveform like PCV but also ensure that a constant tidal volume is delivered to the patient like VCV.
Regardless of the ventilation strategy, general anesthesia inevitably induces atelectasis2, due to different mechanisms such as: shift of the diaphragm towards the thorax thus causing compressions of some lung areas, surfactant alteration due to inhalational anaesthetics, high inspired fractions of oxygen (FiO2) which are reabsorbed from the alveoli into the bloodstream causing reduction of the alveolar size3. These effects are demonstrable both immediately after induction and at the endo of surgery.
Children are particularly vulnerable to anaesthesia-induced atelectasis, due to the relatively higher compliant chest wall and the presence of diaphragmatic compression by large abdominal organs4. The clinical consequences of atelectasis are significant and include increased intrapulmonary shunt (blood passing through the lungs without being oxygenated), perioperative desaturation, higher risk of pneumonia, and a broader spectrum of postoperative pulmonary complications (PPCs)5. Given the peculiarities that predispose paediatric patients to atelectasis, they cannot be considered simply as miniature adults; their unique physiology requires tailored protective ventilation strategies. This highlights the urgency of identifying optimal ventilatory modes capable of minimizing atelectasis in this vulnerable population Since the best ventilatory strategy to avoid atelectasis is not defined currently, with the present randomized clinical trial the investigators aim to compare the effects of two ventilatory modes (VCV and PRVC) at same settings in terms of tidal volume, PEEP, FiO2, on atelectasis as described by lung ultrasound and EIT. The investigators hypnotized that PRVC (combining pressure control with guaranteed tidal volume) reduces atelectasis severity compared to VCV, as measured by LUS and EIT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization: Eligible patients will be randomized in an equal manner (1:1) to receive Volume Control Ventilation (VCV) or Pressure Regulated Volume Control (PRVC/PCV-VG). The randomization sequence will be generated by a computerized system to ensure unpredictability of the assignment. Randomization will be managed by an independent investigator not involved in direct patient care or data collection and will be stratified by center.
| Arm | Type | Receives |
|---|---|---|
| PRVC ventilation | Experimental | Other: PRVC ventilationPatients in this arm will be ventilated in PRVC. |
| VCV ventilation | Active comparator | Other: VCV ventilationPatients in this arm will be ventilated in VCV. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients requiring intraoperative mechanical ventilation via endotracheal intubation
- Written informed consent obtained from parents or legal guardians. For children capable of understanding, assent will also be obtained based on age and cognitive ability.
- ASA (American Society of Anesthesiologists) physical status I-II
Key exclusion criteria (5 listed)
- Patients with significant pre-existing lung disease (e.g., cystic fibrosis, severe bronchopulmonary dysplasia, severe uncontrolled asthma, neuromuscular disease with respiratory compromise).
- Patients with complex congenital heart disease or significant hemodynamic instability.
- Patients undergoing thoracic surgery or procedures that could significantly alter lung mechanics (e.g., pre-existing pneumothorax).
- Refusal of parents/guardians or patient to participate in the study.
- History of previous intrathoracic procedure.
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 ventilationVentilation in PRVC mode. | Other | PRVC ventilation |
| VCV ventilationVentilation in VCV mode. | Other | VCV ventilation |
Primary outcome
Atelectasis at lung ultrasound
Time frame: From baseline to recovery in post-anesthesia care unit
To compare the incidence of intraoperative pulmonary atelectasis, measured by Lung Ultrasound Score (LUS) , between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG).
Atelectasis
Time frame: From baseline to recovery in post-anesthesia care unit
To compare the severity of intraoperative pulmonary atelectasis, measured by EIT, between two different modes of mechanical ventilation: Volume Control Ventilation (VCV) and Pressure Regulated Volume Control (PRVC/PCV-VG).
5 secondary outcomes
Regional distribution of ventilation and lung homogeneity
Time frame: From baseline to recovery in post-anesthesia care unit
Peak Inspiratory Pressure
Time frame: From baseline to recovery in post-anesthesia care unit
Plateau Pressure
Time frame: From baseline to recovery in post-anesthesia care unit
Static Respiratory System Compliance
Time frame: From baseline to recovery in post-anesthesia care unit
Dynamic Respiratory System Compliance
Time frame: From baseline to recovery in post-anesthesia care unit
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 19 Sep 2025.
- Background: PubMed 39369249Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x.
- Background: PubMed 11511953Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021.
- Background: PubMed 31409981Kim YS, Won YJ, Lee DK, Lim BG, Kim H, Lee IO, Yun JH, Kong MH. Lung ultrasound score-based perioperative assessment of pressure-controlled ventilation-volume guaranteed or volume-controlled ventilation in geriatrics: a prospective randomized controlled trial. Clin Interv Aging. 2019 Jul 18;14:1319-1329. doi: 10.2147/CIA.S212334. eCollection 2019.
- Background: PubMed 31351452Bauer M, Opitz A, Filser J, Jansen H, Meffert RH, Germer CT, Roewer N, Muellenbach RM, Kredel M. Perioperative redistribution of regional ventilation and pulmonary function: a prospective observational study in two cohorts of patients at risk for postoperative pulmonary complications. BMC Anesthesiol. 2019 Jul 27;19(1):132. doi: 10.1186/s12871-019-0805-8.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRVC ventilation and VCV ventilation in people with Atelectasis, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Sep 2025. 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 Italy. 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?
Contact Anna Camporesi, M.D. (+393355793744, anna.camporesi@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atelectasis at lung ultrasound (time frame: From baseline to recovery in post-anesthesia care unit). 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?
On the ClinicalTrials.gov record for NCT07182539, which also lists 4 linked publications.
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 19 Sep 2025.