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

NCT07042854 | Completed

• 1 other identifier: 2023/ST/099
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Homogeneity; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Intra-lung Compliance

  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.

  Perioperatory.

Secondary Outcomes (2)

• Global Inhmogeneity Index (GI)

  Perioperatory.

• Regional Ventilation Delay (RVD)

  Perioperatory.

Study Arms (1)

Single cohort

Each patient has received both ventilatory modes with same settings (tidal volume- TV, respiratory rate- RR, positive end expiratory pressure- PEEP- and inspired fraction of Oxygen - FiO2). Intra-lung compliance and global inhomogeneity Index (GI) were assessed though Electric Impedance Tomography (EIT) (PulmoVista 500, Draeger Medical, Germany), allowing at least five minutes after change of mode to let adequate time for gas distribution. At the same time, respiratory mechanics measures were obtained in quasi-static conditions after an inspiratory hold manoeuver, ensuring stability of plateau pressure (PPLAT). We assessed resistive (PIP-PPLAT) and elastic components (DeltaP and quasi-static compliance) of working pressure, and mechanical power as a marker of energy dissipation.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy pediatric patients undergoing general anesthesia requiring endotracheal intubation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Study Sites (1)

Vittore Buzzi Children's Hospital

Milan, 20154, Italy

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• Wang Q, Li Y, Zhao K, Zhang J, Zhou J. Optimizing perioperative lung protection strategies for reducing postoperative respiratory complications in pediatric patients: a narrative review. Transl Pediatr. 2024 Nov 30;13(11):2043-2058. doi: 10.21037/tp-24-453. Epub 2024 Nov 26.

  PMID: 39649647 RESULT

• Nascimento MS, Rebello CM, Costa ELV, Correa LC, Alcala GC, Rossi FS, Morais CCA, Laurenti E, Camara MC, Iasi M, Apezzato MLP, do Prado C, Amato MBP. Effect of general anesthesia and controlled mechanical ventilation on pulmonary ventilation distribution assessed by electrical impedance tomography in healthy children. PLoS One. 2023 Mar 16;18(3):e0283039. doi: 10.1371/journal.pone.0283039. eCollection 2023.

  PMID: 36928465 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Coordinator for Pediatric Anesthesia

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 29, 2025
• Study Start: May 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)