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

NCT07182539 | Not Yet Recruiting

• 1 other identifier: VentiEIT_ped
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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)

Conditions

Atelectasis

Keywords

Atelectasis; Lung Ultrasound; EIT; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  From baseline to recovery in post-anesthesia care unit

Secondary Outcomes (5)

• Regional distribution of ventilation and lung homogeneity

  From baseline to recovery in post-anesthesia care unit

• Peak Inspiratory Pressure

  From baseline to recovery in post-anesthesia care unit

• Plateau Pressure

  From baseline to recovery in post-anesthesia care unit

• Static Respiratory System Compliance

  From baseline to recovery in post-anesthesia care unit

• Dynamic Respiratory System Compliance

  From baseline to recovery in post-anesthesia care unit

Study Arms (2)

PRVC ventilation

EXPERIMENTAL

Patients in this arm will be ventilated in PRVC.

Other: PRVC ventilation

VCV ventilation

ACTIVE COMPARATOR

Patients in this arm will be ventilated in VCV.

Other: VCV ventilation

Interventions

PRVC ventilation OTHER

Ventilation in PRVC mode.

PRVC ventilation

VCV ventilation OTHER

Ventilation in VCV mode.

VCV ventilation

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Study Sites (1)

Vittore Buzzi Children's Hospital

Milan, Italy

Location

Related Publications (4)

• 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.

  PMID: 39369249 BACKGROUND

• Frerichs 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.

  PMID: 11511953 BACKGROUND

• 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.

  PMID: 31409981 BACKGROUND

• Bauer 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.

  PMID: 31351452 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Anna Camporesi, M.D.

CONTACT

+393355793744; anna.camporesi@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be aware of the randomization arm
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Coordinator of Pediatric Anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)