VCV vs PRVC in Pediatric Anesthesia; an EIT- and LS-based Study
ConditionAtelectasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorVittore Buzzi Children's Hospital
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PRVC ventilation
Other interventionVentilation in PRVC mode.
VCV ventilation
Other interventionVentilation in VCV mode.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: PRVC ventilationExperimental treatment 1 intervention
Group B: VCV ventilationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From baseline to recovery in post-anesthesia care unit2
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).
Time frame
From baseline to recovery in post-anesthesia care unitSecondary outcomes
1
Regional distribution of ventilation and lung homogeneity
Compare 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).
Time frame
From baseline to recovery in post-anesthesia care unit2
Peak Inspiratory Pressure
Evaluate the impact of the two ventilation modes on Peak Inspiratory Pressure (PIP).
Time frame
From baseline to recovery in post-anesthesia care unit3
Plateau Pressure
Evaluate the impact of the two ventilation modes on Plateau Pressure.
Time frame
From baseline to recovery in post-anesthesia care unit4
Static Respiratory System Compliance
Evaluate the impact of the two ventilation modes on Static respiratory System Compliance
Time frame
From baseline to recovery in post-anesthesia care unitSponsors and contacts
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Source ClinicalTrials.gov
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