NCT05823688

Brief 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. The objective is to evaluate the impact of general anesthesia and laparoscopy on regional pulmonary ventilation visualized at EIT during the perioperative period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

April 8, 2023

Last Update Submit

May 9, 2024

Conditions

Pediatric AnesthesiaLaparoscopyVentilation

Outcome Measures

Primary Outcomes (1)

  • Regional Ventilation distribution

    Difference in regional ventilation distribution before and after institution of pneumoperitoneum

    Intraoperative

Interventions

Electrical Impedance TomographyDEVICE

Measure of regional ventilation by Electrical Impedance Tomography (EIT) before and during pneumoperitoneum

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients age 10-18 undergoing laparoscopic procedures

You may qualify if:

  • ASA Status I and II
  • elective or urgent laparoscopic procedures (e.g., appendectomy, cholecystectomy, varicocelectomy)

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vittore Buzzi Children's Hospital

Milan, 20154, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Camporesi, M.D.

CONTACT

+393355793744anna.camporesi@asst-fbf-sacco.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2023

First Posted

April 21, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)