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VCV vs PRVC in Pediatric Anesthesia; an EIT- and LS-based Study

Atelectasis in Pediatric Anesthesia: A Randomized Observational Study Comparing Volume-Controlled and Pressure-Regulated Volume Control Ventilation Via Lung Ultrasound and Electrical Impedance Tomography

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07182539
Acronym
VentiEIT_ped
Enrollment
88
Registered
2025-09-19
Start date
2025-09-30
Completion date
2026-01-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis

Keywords

Atelectasis, Lung Ultrasound, EIT, Pediatric Anesthesia

Brief 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 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.

Interventions

Ventilation in PRVC mode.

OTHERVCV ventilation

Ventilation in VCV mode.

Sponsors

Vittore Buzzi Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Patients will not be aware of the randomization arm

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Atelectasis at lung ultrasoundFrom baseline to recovery in post-anesthesia care unitTo 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).
AtelectasisFrom baseline to recovery in post-anesthesia care unitTo 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).

Secondary

MeasureTime frameDescription
Peak Inspiratory PressureFrom baseline to recovery in post-anesthesia care unitEvaluate the impact of the two ventilation modes on Peak Inspiratory Pressure (PIP).
Static Respiratory System ComplianceFrom baseline to recovery in post-anesthesia care unitEvaluate the impact of the two ventilation modes on Static respiratory System Compliance
Dynamic Respiratory System ComplianceFrom baseline to recovery in post-anesthesia care unitEvaluate the impact of the two ventilation modes on Dynamic respiratory System Compliance
Plateau PressureFrom baseline to recovery in post-anesthesia care unitEvaluate the impact of the two ventilation modes on Plateau Pressure.
Regional distribution of ventilation and lung homogeneityFrom baseline to recovery in post-anesthesia care unitCompare 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).

Countries

Italy

Contacts

Primary ContactAnna Camporesi, M.D.
anna.camporesi@asst-fbf-sacco.it+393355793744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026