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Completed

NCT Number: NCT07042854

Volume-Controlled vs Pressure-Regulated Volume Control Ventilation in Pediatric Anesthesia: an Electrical Impedance Tomography Based 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.

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Key information

Conditions

Ventilation Homogeneity Anesthesia

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vittore Buzzi Children's Hospital

Milan, 20154, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists' status 1 and 2
  • Provision of general anesthesia requiring endotracheal intubation

Exclusion criteria

  • chronic lung diseases
  • thoracic surgery
  • thoracic or airway malformation
  • presence of tracheostomy
  • acute pulmonary conditions (secretions, laryngospasm, bronchoconstriction, pneumothorax) during anesthesia

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Global Inhmogeneity Index (GI)

    Time frame: Perioperatory.

    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.

  2. Regional Ventilation Delay (RVD)

    Time frame: Perioperatory.

    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.

Sponsors and collaborators

Lead sponsor

Vittore Buzzi Children's Hospital

Other

Registry information

Acronym: VC_PRVC_ped

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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