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Ventilator LungVentiPedNCT06370507

Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery

An observational study of Ventilator Lung and Surgery, run by Azienda Ospedaliero Universitaria Maggiore della Carita.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 0 days to 14 years
Conditions the study is for
Ventilator Lung, Surgery, Pediatric
What is being tested?
Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery
Type of treatment
Medical device
How many people
800 participants
Where
No sites listed yet
Study dates
15 Apr 2024to 31 Jul 2025
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days to 14 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet.

Gianmaria Cammarota, Prof contact

+393213733406

gianmaria.cammarota@uniupo.it

About this study

Official title: Ventilation Monitoring by Electrical Impedance Tomography During Anesthesia for Pediatric Surgery: an Observational Prospective Data-registry

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.

Read the 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.

Being tested
Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery
Keywords
Electrical impedance tomography, Surgery, Pediatric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT06370507
Study groupRoleWhat they receive
Pediatric patients undergoing sedation or general anesthesiaPediatric patients undergoing sedation or general anesthesia subjected to ventilation distribution assessment via electrical impedance tomography
Receives: Device: Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilation distribution

    Ventilation distribution assessment through Electrical impedance tomography

    Measured: Intraoperative time frame

Secondary outcomes (4)
  1. Intraoperative ventilatory respiratory mechanics

    Respiratory mechanics

    Measured: Intraoperative time frame

  2. Postoperative pulmonary complications

    Postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, atelectasis requiring supplemental oxygen administration or non-invasive respiratory support or invasive mechanical ventilation)

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

  3. Intraoperative oxygenation

    Oxygenation evaluated through peripheral oxygen saturation

    Measured: Intraoperative time frame

  4. Intraoperative hemodynamics

    blood pressure

    Measured: Intraoperative time frame

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start15 Apr 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
800 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370507
Sponsor's protocol ID
UPO2#
Acronym
VentiPed
Status last verified
Apr 2024
First submitted
6 Apr 2024
Last updated
17 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40551255

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilator Lung and Surgery, run by Azienda Ospedaliero Universitaria Maggiore della Carita.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gianmaria Cammarota, Prof (+393213733406, gianmaria.cammarota@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilation distribution (time frame: Intraoperative time frame). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370507, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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