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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07042854

Acronym

VC_PRVC_ped

Enrollment

123

Registered

2025-06-29

Start date

2024-05-01

Completion date

2025-05-30

Last updated

2025-06-29

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

Conditions

Anesthesia, Ventilation Homogeneity

Brief 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 endotracheal intubation.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intra-lung Compliance	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

Measure	Time frame	Description
Global Inhmogeneity Index (GI)	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.
Regional Ventilation Delay (RVD)	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.

Countries

Italy

Outcome results