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

NCT ID: NCT07042854

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventilation Homogeneity Anesthesia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vittore Buzzi Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Camporesi

Medical Coordinator for Pediatric Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vittore Buzzi Children's Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 31409981 (View on PubMed)

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.

Reference Type RESULT
PMID: 39369249 (View on PubMed)

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.

Reference Type RESULT
PMID: 39649647 (View on PubMed)

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.

Reference Type RESULT
PMID: 36928465 (View on PubMed)

Other Identifiers

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2023/ST/099

Identifier Type: -

Identifier Source: org_study_id

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