Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery

NCT ID: NCT06370507

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-07-31

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.

Detailed Description

Anesthesia for surgery is associated with the development of atelectasis and hypoventilation that may persist postoperatively, exposing patients to postoperative pulmonary complications. The main cause is the loss of muscle tone, especially of the diaphragm, which is affected by the pressure exerted by the abdominal viscera, resulting in elevation and compression of alveoli and small airways in the posterior lung regions, leading to collapse and atelectasis, as well as redistribution of ventilation. These variations are even more pronounced in pediatric patients, who have significantly greater chest wall compliance and markedly lower functional residual capacity compared to adults, making them physiologically predisposed to derecruitment during anesthesia. These phenomena are well recognized, but their magnitude and causes are relatively poorly documented due to the scarcity of means capable of precise assessment. EIT is an extremely useful tool as it allows real-time monitoring of changes in the topographic distribution of ventilation in a completely non-invasive manner, highlighting atelectasis and redistribution of aeration. EIT is an imaging technique used in both pediatric and adult patients, analyzing tissue resistivity properties against low-intensity currents applied to the chest via electrodes placed at the IV-VI intercostal spaces. Scans are generated from the collected potential differences and known excitation currents using weighted back-projection into a matrix of pixels. Each pixel represents the instantaneous relative local impedance change compared to a baseline, caused by the presence of a larger or smaller volume of air. This allows for real-time and precise reconstruction of lung air distribution for each breath using dedicated software. In adults, its application in the operating room allows monitoring of lung ventilation distribution during anesthesia, mechanical ventilation, and surgical procedures capable of altering it (such as pneumoperitoneum), optimizing ventilatory settings to avoid atelectasis and derecruitment. Studies in the pediatric field have shown great promise but are significantly limited, mostly conducted in extreme age groups (premature and neonatal) and almost exclusively during spontaneous breathing and without sedation. Pediatric patients undergo a series of respiratory system modifications from birth to adolescence due to lung and alveolar growth, ossification of the rib cage, and muscle tone increase, making the generalization of parameters and findings impossible. Children undergo a series of respiratory system modifications from birth to adolescence due to lung and alveolar growth, ossification of the rib cage, and increased muscle tone, making it impossible to generalize physiological parameters and findings that can vary significantly across different age groups (neonate, infant, preschool-age child, child, adolescent).

Given the scarcity of studies aimed at assessing the effect of anesthesia and surgical technique 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 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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients undergoing sedation or general anesthesia

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

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Children and adolescents under 14 years of age

2. 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Gianmaria Cammarota, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianmaria Cammarota, Prof

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Central Contacts

Gianmaria Cammarota, Prof

Role: CONTACT

gianmaria.cammarota@uniupo.it

+393213733406

References

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.

Reference Type: DERIVED

PMID: 40551255 (View on PubMed)

Other Identifiers

UPO2#

Identifier Type: -

Identifier Source: org_study_id