Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06370507 |
| Other study ID # |
UPO2# |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Azienda Ospedaliero Universitaria Maggiore della Carita |
| Contact |
Gianmaria Cammarota, Prof |
| Phone |
+393213733406 |
| Email |
gianmaria.cammarota[@]uniupo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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.
