Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery

NCT06370507 | Not Yet Recruiting

• 1 other identifier: UPO2#
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Given the scarcity of studies aimed at assessing the effect of anesthesia and m ventilation on the distribution of lung ventilation in pediatric patients undergoing surgery, with the exclusion of thoracic surgery, the present prospective observational study would shed the light on ventilation practice in pediatric anesthesia for surgery. This study wold fill the actual gap allowing the evaluation, through electrical impedance tomography (EIT) of the distribution of lung ventilation across the different phases of anesthesia for pediatric surgery. These insights could contribute to improve clinical practice and research in the management of ventilation in pediatric patients undergoing anesthesia for surgery.

Conditions

Ventilator Lung; Surgery; Pediatric

Keywords

Electrical impedance tomography; Surgery; Pediatric

Outcome Measures

Primary Outcomes (1)

• Ventilation distribution

  Ventilation distribution assessment through Electrical impedance tomography

  Intraoperative time frame

Secondary Outcomes (4)

• Intraoperative ventilatory respiratory mechanics

  Intraoperative time frame

• Postoperative pulmonary complications

  Immediately after surgery till 7th day after intervention or hospital discharge

• Intraoperative oxygenation

  Intraoperative time frame

• Intraoperative hemodynamics

  Intraoperative time frame

Study Arms (1)

Pediatric patients undergoing sedation or general anesthesia

Pediatric patients undergoing sedation or general anesthesia subjected to ventilation distribution assessment via electrical impedance tomography

Device: Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery

Interventions

Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery DEVICE

Assessment of ventilation distribution through electrical impedance tomography in pediatric patients subjected to sedation or general anesthesia for surgery

Pediatric patients undergoing sedation or general anesthesia

Eligibility Criteria

• Age: 0 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children and adolescents under the age of 14 who need to undergo surgical procedures excluding thoracic surgery.

You may qualify if:

• Children and adolescents under 14 years of age
• Elective and urgent surgeries, excluding thoracic surgeries, managed with any anesthesia modality, including:
• Deep sedation with spontaneous breathing associated with regional anesthesia
• Deep sedation with the use of a laryngeal mask for airway control and ventilatory support
• General anesthesia with endotracheal tube placement
• American Society of Anesthesiologists (ASA) I-III classification
• Negative medical history for airway infection with fever in the two weeks preceding the study, three weeks for patients with a personal history of laryngospasm and bronchospasm.

You may not qualify if:

• Age \> 14 years
• ASA \> III
• Known lung pathology
• Lack of parental consent for the study
• Occurrence of serious complications during anesthesia (such as laryngospasm or bronchospasm)

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Related Publications (1)

• Rosalba D, Meneghetti G, Verdina F, Solai C, Azzolina D, Petronio L, Guaraglia M, Buscaglia R, Saviolo G, Furlan G, Vietti F, Biasucci D, Spadaro S, Simonte R, De Robertis E, Longhini F, Penpa S, Ubertazzi M, Panuccio E, Aluffi P, De Cilla S, Brucoli M, Vaschetto R, Cammarota G. Patterns of lung aeration assessed through electrical impedance tomography in paediatric patients undergoing elective surgery: insights from a prospective and observational data-registry. J Anesth Analg Crit Care. 2025 Jun 23;5(1):34. doi: 10.1186/s44158-025-00254-x.

  PMID: 40551255 DERIVED

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Gianmaria Cammarota, Prof

  Università degli Studi del Piemonte Orientale Amedeo Avogadro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmaria Cammarota, Prof

CONTACT

+393213733406; gianmaria.cammarota@uniupo.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 17, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04