Acute Respiratory Distress SyndromeREMAV-EITNCT07402174
EIT- Guided Lung Recruitment in pARDS
A study testing Electrical Impedance Tomography (EIT)-Guided Lung Recruitment in people with Acute Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Electrical Impedance Tomography (EIT)-Guided Lung Recruitment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 1 month and 10 years
- Diagnosis of pediatric Acute Respiratory Distress Syndrome (pARDS) according to PALICC-2 criteria
- Invasive mechanical ventilation for less than 48 hours at the time of enrollment
Who cannot join
- Evidence or history of barotrauma (e.g., pneumothorax, pneumomediastinum)
- Presence of congenital heart disease with hemodynamic significance
- Known or suspected intracranial hypertension
- Presence of an implantable cardioverter-defibrillator (ICD)
- Parental o legal guardian refuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20100
Virginia Figgiaconi, MD, 0039-2-55032242, virginia.figggiaconi@policlinico.mi.it
Mario Madeo, Senior Nurse, 0039-2-55032241, mario.madeo@policlinico.mi.it
Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome
Study Title:
EIT-Guided Lung Recruitment Maneuvers in Pediatric ARDS: Effects on Ventilation Distribution and Respiratory Mechanics
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Electrical Impedance Tomography (EIT)-Guided Lung Recruitment
- Keywords
- Acute Respiratory Distress Syndrome, EIT, Children
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance Tomography (EIT)-Guided Lung RecruitmentDevice
Staircase Recruitment Maneuver
| Study group | Role | What they receive |
|---|---|---|
| EIT-Guided Recruitment | Experimental | This arm includes all participants undergoing a standardized staircase lung recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT is used to assess regional ventilation distribution and guide the titration of PEEP. Mechanical ventilation settings are adjusted based on individual EIT-derived responses. Respiratory mechanics, including transpulmonary pressure and compliance partitioning, are also recorded to evaluate physiological effects of recruitment. Receives: Device: Electrical Impedance Tomography (EIT)-Guided Lung Recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Inhomogeneity Index (GI)
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.
Measured: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Secondary outcomes (3)
Differences in Tidal Impedence
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.
Measured: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Centre of Ventilation (CoV)
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.
Measured: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Changes in Regional Ventilation Delay (RVD) Index
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.
Measured: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Chidini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Giovanna Chidini, MD, Principal investigator, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402174
- Sponsor's protocol ID
- 1170_2021
- Acronym
- REMAV-EIT
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including respiratory mechanics and EIT-derived ventilation metrics, will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results and following approval by the principal investigator and ethics committee.
Publications
Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021.
PubMed 11511953Ren H, Xie L, Wang Z, Tang X, Ning B, Teng T, Qian J, Wang Y, Fu L, Zhao Z, Xiang L. Comparison of Global and Regional Compliance-Guided Positive End-Expiratory Pressure Titration on Regional Lung Ventilation in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2022 May 23;9:805680. doi: 10.3389/fmed.2022.805680. eCollection 2022.
PubMed 35677825Cabezudo Ballesteros S, Sanabria Carretero P, Reinoso Barbero F. Review of electrical impedance tomography in the pediatric patient. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jun-Jul;71(6):479-485. doi: 10.1016/j.redare.2024.03.007. Epub 2024 Mar 6.
PubMed 38458492Soltesz L, Leyens J, Vogel M, Muders T, Putensen C, Kipfmueller F, Dresbach T, Mueller A, Schroeder L. EIT guided evaluation of regional ventilation distributions in neonatal and pediatric ARDS: a prospective feasibility study. Respir Res. 2025 Feb 19;26(1):60. doi: 10.1186/s12931-025-03134-8.
PubMed 39972380Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
PubMed 37046213
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07402174
- Acronym / sponsor ID
- REMAV-EIT / 1170_2021
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, EIT, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Feb 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EIT-Guided Recruitment | Experimental | Device: Electrical Impedance Tomography (EIT)-Guided Lung RecruitmentThis arm includes all participants undergoing a standardized staircase lung recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT is used to assess regional ventilation distribution and guide the titration of PEEP. Mechanical ventilation settings are adjusted based on individual EIT-derived responses. Respiratory mechanics, including transpulmonary pressure and compliance partitioning, are also recorded to evaluate physiological effects of recruitment. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 1 month and 10 years
- Diagnosis of pediatric Acute Respiratory Distress Syndrome (pARDS) according to PALICC-2 criteria
- Invasive mechanical ventilation for less than 48 hours at the time of enrollment
Key exclusion criteria (5 listed)
- Evidence or history of barotrauma (e.g., pneumothorax, pneumomediastinum)
- Presence of congenital heart disease with hemodynamic significance
- Known or suspected intracranial hypertension
- Presence of an implantable cardioverter-defibrillator (ICD)
- Parental o legal guardian refuse
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 Tomography (EIT)-Guided Lung RecruitmentStaircase Recruitment Maneuver | Device | EIT-Guided Recruitment |
Primary outcome
Global Inhomogeneity Index (GI)
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.
3 secondary outcomes
Differences in Tidal Impedence
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Centre of Ventilation (CoV)
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Changes in Regional Ventilation Delay (RVD) Index
Time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 11511953Frerichs I, Schiffmann H, Hahn G, Hellige G. Non-invasive radiation-free monitoring of regional lung ventilation in critically ill infants. Intensive Care Med. 2001 Aug;27(8):1385-94. doi: 10.1007/s001340101021.
- Background: PubMed 35677825Ren H, Xie L, Wang Z, Tang X, Ning B, Teng T, Qian J, Wang Y, Fu L, Zhao Z, Xiang L. Comparison of Global and Regional Compliance-Guided Positive End-Expiratory Pressure Titration on Regional Lung Ventilation in Moderate-to-Severe Pediatric Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2022 May 23;9:805680. doi: 10.3389/fmed.2022.805680. eCollection 2022.
- Background: PubMed 38458492Cabezudo Ballesteros S, Sanabria Carretero P, Reinoso Barbero F. Review of electrical impedance tomography in the pediatric patient. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jun-Jul;71(6):479-485. doi: 10.1016/j.redare.2024.03.007. Epub 2024 Mar 6.
- Background: PubMed 39972380Soltesz L, Leyens J, Vogel M, Muders T, Putensen C, Kipfmueller F, Dresbach T, Mueller A, Schroeder L. EIT guided evaluation of regional ventilation distributions in neonatal and pediatric ARDS: a prospective feasibility study. Respir Res. 2025 Feb 19;26(1):60. doi: 10.1186/s12931-025-03134-8.
- Background: PubMed 37046213Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including respiratory mechanics and EIT-derived ventilation metrics, will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results and following approval by the principal investigator and ethics committee.
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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.
Giovanna Chidini, MD principal investigator
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography (EIT)-Guided Lung Recruitment in people with Acute Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Chidini, MD (0039-2-55032242, giovanna.chidini@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Inhomogeneity Index (GI) (time frame: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery). 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 NCT07402174, which also lists 5 linked publications.
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 11 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.