Ventilation HomogeneityVC_PRVC_pedNCT07042854
Volume-Controlled vs Pressure-Regulated Volume Control Ventilation in Pediatric Anesthesia: an Electrical Impedance Tomography Based Study
An observational study of Ventilation Homogeneity and Anesthesia, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
The primary goal of this prospective, observational crossover study is to investigate mechanical and EIT (Electrical Impedance Tomography) differences between Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Controlled Ventilation (PRVC) in pediatric patients undergoing general anesthesia with… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Ventilation Homogeneity, Anesthesia
- How many people
- 123 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 30 May 2025
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Healthy pediatric patients undergoing general anesthesia requiring endotracheal intubation
Who may be able to join
- American Society of Anesthesiologists' status 1 and 2
- Provision of general anesthesia requiring endotracheal intubation
Who cannot join
- chronic lung diseases
- thoracic surgery
- thoracic or airway malformation
- presence of tracheostomy
- acute pulmonary conditions (secretions, laryngospasm, bronchoconstriction, pneumothorax) during anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this prospective, observational crossover study is to investigate mechanical and EIT (Electrical Impedance Tomography) differences between Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Controlled Ventilation (PRVC) in pediatric patients undergoing general anesthesia with endotracheal intubation.
- Conditions
- Ventilation Homogeneity, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Each patient has received both ventilatory modes with same settings (tidal volume- TV, respiratory rate- RR, positive end expiratory pressure- PEEP- and inspired fraction of Oxygen - FiO2). Intra-lung compliance and global inhomogeneity Index (GI) were assessed though Electric Impedance Tomography (EIT) (PulmoVista 500, Draeger Medical, Germany), allowing at least five minutes after change of mode to let adequate time for gas distribution. At the same time, respiratory mechanics measures were obtained in quasi-static conditions after an inspiratory hold manoeuver, ensuring stability of plateau pressure (PPLAT). We assessed resistive (PIP-PPLAT) and elastic components (DeltaP and quasi-static compliance) of working pressure, and mechanical power as a marker of energy dissipation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-lung Compliance
Intra-lung Compliance is an EIT- based parameter which shows if, between the two modes of ventilation, there is a net gain or loss of intraprenchimal compliance. This is expressed as percentage change from the first-point Compliance measured. We will compare Compliance in PRVC to RVD in VCV ventilation. VCV is the reference point.
Measured: Perioperatory.
Secondary outcomes (2)
Global Inhmogeneity Index (GI)
GI is a EIT-derived index to quantify the tidal volume distribution within the lung. We will compare GI in PRVC to RVD in VCV ventilation. VCV is the reference point.
Measured: Perioperatory.
Regional Ventilation Delay (RVD)
RVD is an index of inhomogeneous ventilation. RVD quantifies the time difference between the onset of ventilation in different lung regions relative to a reference point. We will compare RVD in PRVC to RVD in VCV ventilation. VCV is the reference point.
Measured: Perioperatory.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
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 Ventilation HomogeneityStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
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
- NCT07042854
- Sponsor's protocol ID
- 2023/ST/099
- Acronym
- VC_PRVC_ped
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim 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 31409981Camporesi 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 39369249Wang Q, Li Y, Zhao K, Zhang J, Zhou J. Optimizing perioperative lung protection strategies for reducing postoperative respiratory complications in pediatric patients: a narrative review. Transl Pediatr. 2024 Nov 30;13(11):2043-2058. doi: 10.21037/tp-24-453. Epub 2024 Nov 26.
PubMed 39649647Nascimento MS, Rebello CM, Costa ELV, Correa LC, Alcala GC, Rossi FS, Morais CCA, Laurenti E, Camara MC, Iasi M, Apezzato MLP, do Prado C, Amato MBP. Effect of general anesthesia and controlled mechanical ventilation on pulmonary ventilation distribution assessed by electrical impedance tomography in healthy children. PLoS One. 2023 Mar 16;18(3):e0283039. doi: 10.1371/journal.pone.0283039. eCollection 2023.
PubMed 36928465
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume-Controlled vs Pressure-Regulated Volume Control Ventilation in Pediatric Anesthesia: an Electrical Impedance Tomography Based Study
- ClinicalTrials.gov ID
- NCT07042854
- Acronym / sponsor ID
- VC_PRVC_ped / 2023/ST/099
- Conditions
- Ventilation Homogeneity, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 29 Jun 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 goal of this prospective, observational crossover study is to investigate mechanical and EIT (Electrical Impedance Tomography) differences between Volume-Controlled Ventilation (VCV) and Pressure-Regulated Volume Controlled Ventilation (PRVC) in pediatric patients undergoing general anesthesia with endotracheal intubation.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | –Each patient has received both ventilatory modes with same settings (tidal volume- TV, respiratory rate- RR, positive end expiratory pressure- PEEP- and inspired fraction of Oxygen - FiO2). Intra-lung compliance and global inhomogeneity Index (GI) were assessed though Electric Impedance Tomography (EIT) (PulmoVista 500, Draeger Medical, Germany), allowing at least five minutes after change of mode to let adequate time for gas distribution. At the same time, respiratory mechanics measures were obtained in quasi-static conditions after an inspiratory hold manoeuver, ensuring stability of plateau pressure (PPLAT). We assessed resistive (PIP-PPLAT) and elastic components (DeltaP and quasi-static compliance) of working pressure, and mechanical power as a marker of energy dissipation. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Healthy pediatric patients undergoing general anesthesia requiring endotracheal intubation
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' status 1 and 2
- Provision of general anesthesia requiring endotracheal intubation
Key exclusion criteria (5 listed)
- chronic lung diseases
- thoracic surgery
- thoracic or airway malformation
- presence of tracheostomy
- acute pulmonary conditions (secretions, laryngospasm, bronchoconstriction, pneumothorax) during anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra-lung Compliance
Time frame: Perioperatory.
Intra-lung Compliance is an EIT- based parameter which shows if, between the two modes of ventilation, there is a net gain or loss of intraprenchimal compliance. This is expressed as percentage change from the first-point Compliance measured. We will compare Compliance in PRVC to RVD in VCV ventilation. VCV is the reference point.
2 secondary outcomes
Global Inhmogeneity Index (GI)
Time frame: Perioperatory.
Regional Ventilation Delay (RVD)
Time frame: Perioperatory.
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 29 Jun 2025.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 39649647Wang Q, Li Y, Zhao K, Zhang J, Zhou J. Optimizing perioperative lung protection strategies for reducing postoperative respiratory complications in pediatric patients: a narrative review. Transl Pediatr. 2024 Nov 30;13(11):2043-2058. doi: 10.21037/tp-24-453. Epub 2024 Nov 26.
- Results publication: PubMed 36928465Nascimento MS, Rebello CM, Costa ELV, Correa LC, Alcala GC, Rossi FS, Morais CCA, Laurenti E, Camara MC, Iasi M, Apezzato MLP, do Prado C, Amato MBP. Effect of general anesthesia and controlled mechanical ventilation on pulmonary ventilation distribution assessed by electrical impedance tomography in healthy children. PLoS One. 2023 Mar 16;18(3):e0283039. doi: 10.1371/journal.pone.0283039. eCollection 2023.
- 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.
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?
An observational study of Ventilation Homogeneity and Anesthesia, 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 2 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: finished, as of the sponsor's last update on 29 Jun 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?
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?
Intra-lung Compliance (time frame: Perioperatory.). 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 NCT07042854, 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 29 Jun 2025.