Electrical Impedance Tomography (EIT)-Guided Lung Recruitment
DeviceStaircase Recruitment Maneuver
NCT Number: NCT07402174
Study Title:
EIT-Guided Lung Recruitment Maneuvers in Pediatric ARDS: Effects on Ventilation Distribution and Respiratory Mechanics
Study Objective:
The primary goal of this clinical trial is to determine whether lung recruitment maneuvers guided by Electrical Impedance Tomography (EIT) result in a more homogeneous ventilation distribution and less injurious ventilation in children with pediatric Acute Respiratory Distress Syndrome (pARDS). The study will assess changes in intrapulmonary gas distribution and respiratory mechanics during recruitment maneuvers using both EIT and partitioned respiratory mechanics.
This is a prospective cohort study involving children diagnosed with pARDS. Eligible participants will be consecutively enrolled over time and will undergo a standardized series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be individualized and titrated based on the EIT-derived response to recruitment.
Main Research Questions:
How can lung recruitment maneuvers be performed safely in children with pARDS? How can we monitor the physiological effects of recruitment on respiratory mechanics? How does recruitment influence the distribution of ventilation within the lungs?
Eligible participants will undergo a series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be titrated and individualized based on the EIT-derived response to recruitment.
Trial opening soon.
Get Notified1 month–10 year
All sexes
Interventional
Not applicable
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy
This is a prospective, single-center, interventional physiological study aiming to assess the effects of EIT-guided lung recruitment maneuvers on ventilation distribution and respiratory mechanics in children with pediatric acute respiratory distress syndrome (pARDS).
A total of 8 mechanically ventilated children diagnosed with moderate-to-severe pARDS will be enrolled within 48 hours from intubation. All patients will undergo a standardized staircase recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT will be used to assess regional ventilation distribution and guide the titration of PEEP to minimize lung collapse and overdistension. Partitioned respiratory mechanics will be measured through esophageal pressure monitoring to assess changes in lung and chest wall compliance, as well as transpulmonary pressure.
Primary outcome is the change in global inhomogeneity index (GI Index) measured before and after recruitment. Secondary outcomes include center of ventilation (CoV), regional ventilation delay (RVD).
Will also considerd overdistension and collapse percentages, changes in lung/chest wall mechanics.
This pilot study will provide physiological data to inform the design of future randomized trials on EIT-guided mechanical ventilation strategies in pediatric ARDS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Staircase Recruitment Maneuver
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
The Global Inhomogeneity Index (GI) is an EIT-derived quantitative measure of ventilation distribution heterogeneity across the lungs. A lower GI index indicates more homogeneous ventilation. GI will be calculated before and after the EIT-guided recruitment maneuver to assess the effect on regional ventilation distribution.
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Tidal impedance is a parameter derived from electrical impedance tomography (EIT) that reflects the regional distribution of ventilation during a tidal breath. Changes in electrical impedance measured between end-expiration and end-inspiration are proportional to changes in lung air volume, allowing real-time, bedside assessment of ventilation distribution.
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
The centre of ventilation is a quantitative measure that describes the geometric mean location of tidal ventilation within the lung along a predefined axis, most commonly the ventral-dorsal or cranio-caudal axis.
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
The RVD index quantifies the delay in regional ventilation during tidal breathing, indicating the degree of tidal recruitment or delayed filling. It reflects regional mechanical heterogeneity and is expected to decrease after effective lung recruitment.
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Chest wall and lung elastance, measured by esophageal pressure monitorin
Contact information is provided by the study sponsor or research team.
Giovanna Chidini, MD
CONTACT
Stefano Scalia Catenacci, MD
CONTACT
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Other
EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome
Acronym: REMAV-EIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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