ARDSREMAV-EITNCT06067152
REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS
A study testing EIT measurement, Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial and Setting of EIT-guided mechanical ventilation in people with ARDS and Pediatric Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
There is evidence from randomized controlled trials in adult patients with Acute Respiratory Distress Syndrome (ARDS) suggesting that delivering small tidal volumes with adequate levels of Positive End-Expiratory Pressure (PEEP) and a restrictive fluid strategy could improve outcome. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- ARDS, Pediatric Respiratory Distress Syndrome, Respiratory Disease
- What is being tested?
- EIT measurement, Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial and Setting of EIT-guided mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 30 Jan 2024
- Phase
- Interventional
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intubated and mechanically ventilated children, ageing 1 months-5 years and meeting the PALICC definition for pediatric Acute Respiratory Distress Syndrome (pARDS)
- Informed Consent signed
- Exclusion Criteria: Patients with one or more of the following characteristics:
- Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema)
- Signs of intracranial hypertension
- Cyanotic congenital cardiac disease
Show all 9Show fewer
- Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
- Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)
- Controindication to positioning the esophageal catheter (surgery, esophageal stenosis)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
Milan, 20122
Giovanna Chidini, MD, 0255032242, giovanna.chidini@policlinico.mi.it
Giovanna Chidini, MD, giovanna.chidini@policlinico.mi.it
About this study
Official title: REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)
There is evidence from randomized controlled trials in adult patients with Acute Respiratory Distress Syndrome (ARDS) suggesting that delivering small tidal volumes with adequate levels of Positive End-Expiratory Pressure (PEEP) and a restrictive fluid strategy could improve outcome. However, there are data and common bedside experience that individual patients may or may not respond to interventions, such as escalation of PEEP or positional changes, and there may be a role for a more personalized ventilator strategy.
This strategy could account for the unique individual morphology of lung disease, such as the amount of atelectasis and overdistension as a percentage of total lung tissue, the exact location of atelectasis, and whether positional changes or elevation of PEEP produce lung recruitment or overdistension.
Read more
Stepwise Recruitment maneuvers (SRMs) in pARDS improve oxygenation in majority of patients. SRMs should be considered for use on an individualized basis in patients with pARDS should be considered if SpO2 decreases by ≥ 5% within 5 minutes of disconnection during suction or coughing or agitation. If a recruitment maneuver is conducted, a decremental PEEP trial must be done to determine the minimum PEEP that sustains the benefits of the recruitment maneuver.
Electrical impedance tomography (EIT), a bedside monitor to describe regional lung volume changes, displays a real-time cross-sectional image of the lung. EIT is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable. It allows to study ventilation distribution dividing lungs in four Region Of Interest (ROI), that are layers distributed in an anteroposterior direction, and shows how ventilation is distributed in the areas concerned.
EIT measures and calculates other parameters that are related not only to the distribution of ventilation, but also to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as SRMs or PEEP-application.
Aim of this study is to provide a protocolized strategy to assess optimal recruitment and PEEP setting, tailored on the patients individual response in pARDS.
- Being tested
- EIT measurement, Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial, Setting of EIT-guided mechanical ventilation, Reevaluation after 24 h
- Keywords
- Non invasive ventilation, electrical impedance tomography;
- Medical subject headings
- Respiratory Distress Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT measurementDevice
Evaluation of mechanical ventilation and ventilation distribution through EIT. Mechanical ventilation is set by the physician according to clinical protocolized criteria
Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trialDevice
Also called SRMs EIT-guided and DP trial
SRMs will be performed with a standardized ventilation protocol. Patient will be sedated, paralyzed and ventilated in pressure controlled mode, FIO2 to obtain SPO2> 92%, RR 25, I:E =1:1.5. Alarm of pressure limit will be set at 35 cmH2O. The ventilator will be equipped with inspiratory and expiratory hold taste. Inspiratory and expiratory occlusion will be held for 5 seconds, data will be stored and analyzed with the ventilator own tool.
Decremental PEEP trial will start if plateau pressure 30 cmH2O will be reached or end inspiratory transpulmonary pressure will exceed 28 cmH2O value. Once reached this level of plateau or transpulmonary pressure, PEEP will be reduced in three steps from 12, 10 and finally to 8 cmH2O every 20 minutes
Setting of EIT-guided mechanical ventilationDevice
Mechanical ventilation is set according to EIT measurement
Reevaluation after 24 hDevice
Evaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided
| Study group | Role | What they receive |
|---|---|---|
| T0= Enrollment | Active comparator | mechanical ventilation will be set according to the standard of care criteria Receives: Device: EIT measurement |
| T1= guided MV at the end of SRM trial | Active comparator | EIT guided mechanical ventilation will be set Receives: Device: Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial; Device: Setting of EIT-guided mechanical ventilation |
| T2= 24 hours with EIT guided MV | Active comparator | evaluation of mechanical ventilation after 24h EIT-guided ventilation Receives: Device: Reevaluation after 24 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Ventilation Delay, RDV (pixels %), at T2 and T0
RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation
Measured: 1 day
Secondary outcomes (13)
Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2
for every breathing cycle, a so-called tidal image is generated and each pixel of represents the difference in impedance between end-inspiration and end-expiration. The median value of each tidal image is calculated for the lung area
Measured: 1 day
Gravity Centre, GC, differences (pixels %) at T0, T1 and T2
it is the weighted mean of row sums obtained from TV image and it indicates ventral-to-dorsal shifts in ventilation distribution due to lung opening and closing
Measured: 1 day
Respiratory Rate at T0, T1 and T2
Respiratory rate (breaths/min)
Measured: 1 day
FiO2 (%) at T0, T1 and T2
FiO2 (%)
Measured: 1 day
Respiratory compliance at T0, T1 and T2
Respiratory System Compliance
Measured: 1 day
Lung compliance at T0, T1 and T2
Clung Lung compliance
Measured: 1 day
Chest Wall compliance at T0, T1 and T2
Chest Wall compliance
Measured: 1 day
S/F ratio at T0, T1 and T2
S/F ratio
Measured: 1 day
Sistolic Blood Pressure at T0, T1 and T2
SBP (mmHg)
Measured: 1 day
Diastolic Blood Pressure at T0, T1 and T2
DBP (mmHg)
Measured: 1 day
pH at T0, T1 and T2
pH
Measured: 1 day
SpO2 at T0, T1 and T2
SpO2 (%)
Measured: 1 day
PaO2 at T0, T1 and T2
PaO2 (mmHg)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Chidini, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067152
- Sponsor's protocol ID
- REMAV-EIT
- Acronym
- REMAV-EIT
- Status last verified
- Aug 2023
- First submitted
- 8 Sep 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
PubMed 20197533National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
PubMed 16714767Wolf GK, Gomez-Laberge C, Kheir JN, Zurakowski D, Walsh BK, Adler A, Arnold JH. Reversal of dependent lung collapse predicts response to lung recruitment in children with early acute lung injury. Pediatr Crit Care Med. 2012 Sep;13(5):509-15. doi: 10.1097/PCC.0b013e318245579c.
PubMed 22622650Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
PubMed 16641394Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
PubMed 20843245Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R; Prone-Supine Study Group. Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med. 2001 Aug 23;345(8):568-73. doi: 10.1056/NEJMoa010043.
PubMed 11529210Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PubMed 23688302Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
PubMed 14693669Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, Magnusson A, Hedenstierna G, Putensen C. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008 Mar;36(3):903-9. doi: 10.1097/CCM.0B013E3181652EDD.
PubMed 18431279Wolf GK, Gomez-Laberge C, Rettig JS, Vargas SO, Smallwood CD, Prabhu SP, Vitali SH, Zurakowski D, Arnold JH. Mechanical ventilation guided by electrical impedance tomography in experimental acute lung injury. Crit Care Med. 2013 May;41(5):1296-304. doi: 10.1097/CCM.0b013e3182771516.
PubMed 23474677Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
PubMed 19652949Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Correction to: Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Sep 4;19(1):172. doi: 10.1186/s12871-019-0840-5.
PubMed 31481006Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
PubMed 25647235Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.
PubMed 28936698
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)
- ClinicalTrials.gov ID
- NCT06067152
- Acronym / sponsor ID
- REMAV-EIT / REMAV-EIT
- Keywords
- Non invasive ventilation, electrical impedance tomography;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 4 Oct 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.
There is evidence from randomized controlled trials in adult patients with Acute Respiratory Distress Syndrome (ARDS) suggesting that delivering small tidal volumes with adequate levels of Positive End-Expiratory Pressure (PEEP) and a restrictive fluid strategy could improve outcome. However, there are data and common bedside experience that individual patients may or may not respond to interventions, such as escalation of PEEP or positional changes, and there may be a role for a more personalized ventilator strategy.
This strategy could account for the unique individual morphology of lung disease, such as the amount of atelectasis and overdistension as a percentage of total lung tissue, the exact location of atelectasis, and whether positional changes or elevation of PEEP produce lung recruitment or overdistension.
Stepwise Recruitment maneuvers (SRMs) in pARDS improve oxygenation in majority of patients. SRMs should be considered for use on an individualized basis in patients with pARDS should be considered if SpO2 decreases by ≥ 5% within 5 minutes of disconnection during suction or coughing or agitation. If a recruitment maneuver is conducted, a decremental PEEP trial must be done to determine the minimum PEEP that sustains the benefits of the recruitment maneuver.
Electrical impedance tomography (EIT), a bedside monitor to describe regional lung volume changes, displays a real-time cross-sectional image of the lung. EIT is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable. It allows to study ventilation distribution dividing lungs in four Region Of Interest (ROI), that are layers distributed in an anteroposterior direction, and shows how ventilation is distributed in the areas concerned.
EIT measures and calculates other parameters that are related not only to the distribution of ventilation, but also to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as SRMs or PEEP-application.
Aim of this study is to provide a protocolized strategy to assess optimal recruitment and PEEP setting, tailored on the patients individual response in pARDS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T0= Enrollment | Active comparator | Device: EIT measurementmechanical ventilation will be set according to the standard of care criteria |
| T1= guided MV at the end of SRM trial | Active comparator | Device: Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial, Device: Setting of EIT-guided mechanical ventilationEIT guided mechanical ventilation will be set |
| T2= 24 hours with EIT guided MV | Active comparator | Device: Reevaluation after 24 hevaluation of mechanical ventilation after 24h EIT-guided ventilation |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Intubated and mechanically ventilated children, ageing 1 months-5 years and meeting the PALICC definition for pediatric Acute Respiratory Distress Syndrome (pARDS)
- Informed Consent signed
- Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema)
- Signs of intracranial hypertension
- Cyanotic congenital cardiac disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EIT measurementEvaluation of mechanical ventilation and ventilation distribution through EIT. Mechanical ventilation is set by the physician according to clinical protocolized criteria | Device | T0= Enrollment |
| Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trialAlso: SRMs EIT-guided and DP trialSRMs will be performed with a standardized ventilation protocol. Patient will be sedated, paralyzed and ventilated in pressure controlled mode, FIO2 to obtain SPO2> 92%, RR 25, I:E =1:1.5. Alarm of pressure limit will be set at 35 cmH2O. The ventilator will be equipped with inspiratory and expiratory hold taste. Inspiratory and expiratory occlusion will be held for 5 seconds, data will be stored and analyzed with the ventilator own tool. Decremental PEEP trial will start if plateau pressure 30 cmH2O will be reached or end inspiratory transpulmonary pressure will exceed 28 cmH2O value. Once reached this level of plateau or transpulmonary pressure, PEEP will be reduced in three steps from 12, 10 and finally to 8 cmH2O every 20 minutes | Device | T1= guided MV at the end of SRM trial |
| Setting of EIT-guided mechanical ventilationMechanical ventilation is set according to EIT measurement | Device | T1= guided MV at the end of SRM trial |
| Reevaluation after 24 hEvaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided | Device | T2= 24 hours with EIT guided MV |
Primary outcome
Regional Ventilation Delay, RDV (pixels %), at T2 and T0
Time frame: 1 day
RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation
13 secondary outcomes
Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2
Time frame: 1 day
Gravity Centre, GC, differences (pixels %) at T0, T1 and T2
Time frame: 1 day
Respiratory Rate at T0, T1 and T2
Time frame: 1 day
FiO2 (%) at T0, T1 and T2
Time frame: 1 day
Respiratory compliance at T0, T1 and T2
Time frame: 1 day
Lung compliance at T0, T1 and T2
Time frame: 1 day
Chest Wall compliance at T0, T1 and T2
Time frame: 1 day
S/F ratio at T0, T1 and T2
Time frame: 1 day
Sistolic Blood Pressure at T0, T1 and T2
Time frame: 1 day
Diastolic Blood Pressure at T0, T1 and T2
Time frame: 1 day
pH at T0, T1 and T2
Time frame: 1 day
SpO2 at T0, T1 and T2
Time frame: 1 day
PaO2 at T0, T1 and T2
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Results publication: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Results publication: PubMed 20197533Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
- Results publication: PubMed 16714767National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
- Results publication: PubMed 22622650Wolf GK, Gomez-Laberge C, Kheir JN, Zurakowski D, Walsh BK, Adler A, Arnold JH. Reversal of dependent lung collapse predicts response to lung recruitment in children with early acute lung injury. Pediatr Crit Care Med. 2012 Sep;13(5):509-15. doi: 10.1097/PCC.0b013e318245579c.
- Results publication: PubMed 16641394Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
- Results publication: PubMed 20843245Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
- Results publication: PubMed 11529210Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R; Prone-Supine Study Group. Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med. 2001 Aug 23;345(8):568-73. doi: 10.1056/NEJMoa010043.
- Results publication: PubMed 23688302Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
- Results publication: PubMed 14693669Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
- Results publication: PubMed 18431279Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, Magnusson A, Hedenstierna G, Putensen C. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008 Mar;36(3):903-9. doi: 10.1097/CCM.0B013E3181652EDD.
- Results publication: PubMed 23474677Wolf GK, Gomez-Laberge C, Rettig JS, Vargas SO, Smallwood CD, Prabhu SP, Vitali SH, Zurakowski D, Arnold JH. Mechanical ventilation guided by electrical impedance tomography in experimental acute lung injury. Crit Care Med. 2013 May;41(5):1296-304. doi: 10.1097/CCM.0b013e3182771516.
- Results publication: PubMed 19652949Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
- National Heart, Lung, and Blood Institute ARDS Clinical Trials Network: Mechanical Ventilation Protocol Summary. 2008Link provided by the sponsor.
- 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.
Giovanna Chidini, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT measurement, Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial and Setting of EIT-guided mechanical ventilation in people with ARDS and Pediatric Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 9 inclusion and 0 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 4 Oct 2023. 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 Giovanna Chidini, MD (0255032242, 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?
Regional Ventilation Delay, RDV (pixels %), at T2 and T0 (time frame: 1 day). 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 NCT06067152, which also lists 23 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 4 Oct 2023.