Pediatric AnesthesiaPulmopneumoNCT05823688
Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy
An observational study of Pediatric Anesthesia and Laparoscopy, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
The goal of this prospective, observational study is to describe EIT measurements at different time points during the perioperative period in healthy children undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Anesthesia, Laparoscopy, Ventilation
- What is being tested?
- Electrical Impedance Tomography
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 31 Dec 2024
- 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 10 to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients age 10-18 undergoing laparoscopic procedures
Who may be able to join
- ASA Status I and II
- elective or urgent laparoscopic procedures (e.g., appendectomy, cholecystectomy, varicocelectomy)
Who cannot join
- Lack of parental consent
- ASA status III-IV
- Presence of peritonitis or other abdominal inflammatory process that could potentially interfere with spontaneous breathing ventilation
- Need for immediate resuscitation maneuvers
- Severe respiratory illness in the previous 4-6 weeks
- Pre-existing chronic pulmonary conditions
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- Concomitant acute pulmonary conditions (e.g. pneumonia, pleural effusion)
- Cardiac arrest
- Skeletal deformities (e.g. rib cage malformations or scoliosis), neuromuscular diseases or cardiac conditions affecting respiratory mechanics
- BMI > 30
- Presence of implantable devices not compatible with EIT (such as pacemakers and implantable defibrillators)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vittore Buzzi Children's Hospital
Milan, 20154
Anna Camporesi, M.D., anna.camporesi@asst-fbf-sacco.it
About this study
Official title: Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy: an Observational Study
The goal of this prospective, observational study is to describe EIT measurements at different time points during the perioperative period in healthy children undergoing laparoscopic surgery. The objective is to evaluate the impact of general anesthesia and laparoscopy on regional pulmonary ventilation visualized at EIT during the perioperative period.
Read the detailed description
Electrical impedance tomography (EIT) is a non-invasive, radiation-free functional imaging technique based on image reconstruction of pulmonary regional ventilation by estimating the changes in resistivity (impedance) that occur in the lungs during respiration. Validation data confirms that EIT is highly reproducible and that impedance changes accurately reflect changes in regional ventilation. This allows for the derivation of EIT-derived measurements that can be used to assess bedside regional lung function.
In clinical practice there is increasing emphasis on understanding the impact of anesthesia and mechanical ventilation on regional pulmonary ventilation in order to improve clinical outcomes, including in children.
Several studies have demonstrated that the benefits of using EIT to set ventilatory parameters, improving gas exchange and respiratory mechanics are also applicable outside the intensive care unit. For example, monitoring of changes in regional ventilation in the operating room in adults has been studied to guide intraoperative ventilation setting and adopt it as a strategy to prevent anesthesia-induced atelectasis.
The impact on regional pulmonary ventilation distribution may be significant in situations such as laparoscopic surgery, where capnoperitoneum and Trendelenburg position pose an additional risk of deterioration of respiratory function and may contribute to the development of early postoperative pulmonary complications.In the adult population, studies demonstrate that pneumoperitoneum during laparoscopy can influence the distribution of ventilation together with anesthesia and mechanical ventilation in different ways. In contrast, regional ventilation changes during laparoscopy are still lacking for the pediatric population.
The aim of the present study is to investigate how general anesthesia and capnoperitoneum during laparoscopic procedures can affect the distribution of regional ventilation displayed by EIT in healthy pediatric patients and how these changes correlate with ventilatory parameters and clinical outcomes.
- Conditions
- Pediatric Anesthesia, Laparoscopy, Ventilation
- Being tested
- Electrical Impedance Tomography
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
Measure of regional ventilation by Electrical Impedance Tomography (EIT) before and during pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Ventilation distribution
Difference in regional ventilation distribution before and after institution of pneumoperitoneum
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 May 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Camporesi, Vittore Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823688
- Sponsor's protocol ID
- EITPEDLAP
- Acronym
- Pulmopneumo
- Status last verified
- May 2024
- First submitted
- 8 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography (EIT) Monitoring of Regional Ventilation During Pediatric Laparoscopy: an Observational Study
- ClinicalTrials.gov ID
- NCT05823688
- Acronym / sponsor ID
- Pulmopneumo / EITPEDLAP
- Conditions
- Pediatric Anesthesia, Laparoscopy, Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, observational study is to describe EIT measurements at different time points during the perioperative period in healthy children undergoing laparoscopic surgery. The objective is to evaluate the impact of general anesthesia and laparoscopy on regional pulmonary ventilation visualized at EIT during the perioperative period.
Detailed description
Electrical impedance tomography (EIT) is a non-invasive, radiation-free functional imaging technique based on image reconstruction of pulmonary regional ventilation by estimating the changes in resistivity (impedance) that occur in the lungs during respiration. Validation data confirms that EIT is highly reproducible and that impedance changes accurately reflect changes in regional ventilation. This allows for the derivation of EIT-derived measurements that can be used to assess bedside regional lung function.
In clinical practice there is increasing emphasis on understanding the impact of anesthesia and mechanical ventilation on regional pulmonary ventilation in order to improve clinical outcomes, including in children.
Several studies have demonstrated that the benefits of using EIT to set ventilatory parameters, improving gas exchange and respiratory mechanics are also applicable outside the intensive care unit. For example, monitoring of changes in regional ventilation in the operating room in adults has been studied to guide intraoperative ventilation setting and adopt it as a strategy to prevent anesthesia-induced atelectasis.
The impact on regional pulmonary ventilation distribution may be significant in situations such as laparoscopic surgery, where capnoperitoneum and Trendelenburg position pose an additional risk of deterioration of respiratory function and may contribute to the development of early postoperative pulmonary complications.In the adult population, studies demonstrate that pneumoperitoneum during laparoscopy can influence the distribution of ventilation together with anesthesia and mechanical ventilation in different ways. In contrast, regional ventilation changes during laparoscopy are still lacking for the pediatric population.
The aim of the present study is to investigate how general anesthesia and capnoperitoneum during laparoscopic procedures can affect the distribution of regional ventilation displayed by EIT in healthy pediatric patients and how these changes correlate with ventilatory parameters and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients age 10-18 undergoing laparoscopic procedures
Key inclusion criteria (2 listed)
- ASA Status I and II
- elective or urgent laparoscopic procedures (e.g., appendectomy, cholecystectomy, varicocelectomy)
Key exclusion criteria (11 listed)
- Lack of parental consent
- ASA status III-IV
- Presence of peritonitis or other abdominal inflammatory process that could potentially interfere with spontaneous breathing ventilation
- Need for immediate resuscitation maneuvers
- Severe respiratory illness in the previous 4-6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance TomographyMeasure of regional ventilation by Electrical Impedance Tomography (EIT) before and during pneumoperitoneum | Device | – |
Primary outcome
Regional Ventilation distribution
Time frame: Intraoperative
Difference in regional ventilation distribution before and after institution of pneumoperitoneum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Anesthesia and Laparoscopy, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
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 2 inclusion and 11 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Anna Camporesi, M.D. (+393355793744, anna.camporesi@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Ventilation distribution (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.