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REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS (REMAV-EIT)

Primary Purpose

ARDS, Pediatric Respiratory Distress Syndrome, Respiratory Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EIT measurement
Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial
Setting of EIT-guided mechanical ventilation
Reevaluation after 24 h
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ARDS focused on measuring Non invasive ventilation, electrical impedance tomography;

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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)

Sites / Locations

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico MilanoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

T0= Enrollment

T1= guided MV at the end of SRM trial

T2= 24 hours with EIT guided MV

Arm Description

mechanical ventilation will be set according to the standard of care criteria

EIT guided mechanical ventilation will be set

evaluation of mechanical ventilation after 24h EIT-guided ventilation

Outcomes

Primary Outcome Measures

Regional Ventilation Delay, RDV (pixels %), at T2 and T0
RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation

Secondary Outcome Measures

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
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
Respiratory Rate at T0, T1 and T2
Respiratory rate (breaths/min)
FiO2 (%) at T0, T1 and T2
FiO2 (%)
Respiratory compliance at T0, T1 and T2
Respiratory System Compliance
Lung compliance at T0, T1 and T2
Clung Lung compliance
Chest Wall compliance at T0, T1 and T2
Chest Wall compliance
S/F ratio at T0, T1 and T2
S/F ratio
Sistolic Blood Pressure at T0, T1 and T2
SBP (mmHg)
Diastolic Blood Pressure at T0, T1 and T2
DBP (mmHg)
pH at T0, T1 and T2
pH
SpO2 at T0, T1 and T2
SpO2 (%)
PaO2 at T0, T1 and T2
PaO2 (mmHg)

Full Information

First Posted
September 8, 2022
Last Updated
September 27, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT06067152
Brief Title
REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS
Acronym
REMAV-EIT
Official Title
REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Pediatric Respiratory Distress Syndrome, Respiratory Disease
Keywords
Non invasive ventilation, electrical impedance tomography;

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T0= Enrollment
Arm Type
Active Comparator
Arm Description
mechanical ventilation will be set according to the standard of care criteria
Arm Title
T1= guided MV at the end of SRM trial
Arm Type
Active Comparator
Arm Description
EIT guided mechanical ventilation will be set
Arm Title
T2= 24 hours with EIT guided MV
Arm Type
Active Comparator
Arm Description
evaluation of mechanical ventilation after 24h EIT-guided ventilation
Intervention Type
Device
Intervention Name(s)
EIT measurement
Intervention Description
Evaluation of mechanical ventilation and ventilation distribution through EIT. Mechanical ventilation is set by the physician according to clinical protocolized criteria
Intervention Type
Device
Intervention Name(s)
Staircase Recruitment Maneuvers with EIT guided and decremental PEEP trial
Other Intervention Name(s)
SRMs EIT-guided and DP trial
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Setting of EIT-guided mechanical ventilation
Intervention Description
Mechanical ventilation is set according to EIT measurement
Intervention Type
Device
Intervention Name(s)
Reevaluation after 24 h
Intervention Description
Evaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided
Primary Outcome Measure Information:
Title
Regional Ventilation Delay, RDV (pixels %), at T2 and T0
Description
RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2
Description
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
Time Frame
1 day
Title
Gravity Centre, GC, differences (pixels %) at T0, T1 and T2
Description
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
Time Frame
1 day
Title
Respiratory Rate at T0, T1 and T2
Description
Respiratory rate (breaths/min)
Time Frame
1 day
Title
FiO2 (%) at T0, T1 and T2
Description
FiO2 (%)
Time Frame
1 day
Title
Respiratory compliance at T0, T1 and T2
Description
Respiratory System Compliance
Time Frame
1 day
Title
Lung compliance at T0, T1 and T2
Description
Clung Lung compliance
Time Frame
1 day
Title
Chest Wall compliance at T0, T1 and T2
Description
Chest Wall compliance
Time Frame
1 day
Title
S/F ratio at T0, T1 and T2
Description
S/F ratio
Time Frame
1 day
Title
Sistolic Blood Pressure at T0, T1 and T2
Description
SBP (mmHg)
Time Frame
1 day
Title
Diastolic Blood Pressure at T0, T1 and T2
Description
DBP (mmHg)
Time Frame
1 day
Title
pH at T0, T1 and T2
Description
pH
Time Frame
1 day
Title
SpO2 at T0, T1 and T2
Description
SpO2 (%)
Time Frame
1 day
Title
PaO2 at T0, T1 and T2
Description
PaO2 (mmHg)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanna Chidini, MD
Phone
0255032242
Email
giovanna.chidini@policlinico.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Scalia-Catenacci, MD
Phone
0255032242
Email
stefani.scaliacatenacci@policlinico.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Chidini, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Chidini, MD
Phone
0255032242
Email
giovanna.chidini@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Giovanna Chidini, MD
Email
giovanna.chidini@policlinico.mi.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10793162
Citation
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.
Results Reference
result
PubMed Identifier
20197533
Citation
Briel 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 Reference
result
PubMed Identifier
16714767
Citation
National 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 Reference
result
PubMed Identifier
22622650
Citation
Wolf 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 Reference
result
PubMed Identifier
16641394
Citation
Gattinoni 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 Reference
result
PubMed Identifier
20843245
Citation
Papazian 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 Reference
result
PubMed Identifier
11529210
Citation
Gattinoni 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 Reference
result
PubMed Identifier
23688302
Citation
Guerin 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 Reference
result
PubMed Identifier
14693669
Citation
Victorino 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 Reference
result
PubMed Identifier
18431279
Citation
Wrigge 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 Reference
result
PubMed Identifier
23474677
Citation
Wolf 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 Reference
result
PubMed Identifier
19652949
Citation
Zhao 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.
Results Reference
result
PubMed Identifier
31481006
Citation
Spinelli 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.
Results Reference
result
PubMed Identifier
25647235
Citation
Pediatric 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.
Results Reference
result
PubMed Identifier
28936698
Citation
Kneyber 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.
Results Reference
result
PubMed Identifier
18451319
Citation
Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.
Results Reference
result
PubMed Identifier
21297069
Citation
Protti A, Cressoni M, Santini A, Langer T, Mietto C, Febres D, Chierichetti M, Coppola S, Conte G, Gatti S, Leopardi O, Masson S, Lombardi L, Lazzerini M, Rampoldi E, Cadringher P, Gattinoni L. Lung stress and strain during mechanical ventilation: any safe threshold? Am J Respir Crit Care Med. 2011 May 15;183(10):1354-62. doi: 10.1164/rccm.201010-1757OC. Epub 2011 Feb 4. Erratum In: Am J Respir Crit Care Med. 2012 Jan 1;185(1):115.
Results Reference
result
PubMed Identifier
25112501
Citation
Chiumello D, Cressoni M, Colombo A, Babini G, Brioni M, Crimella F, Lundin S, Stenqvist O, Gattinoni L. The assessment of transpulmonary pressure in mechanically ventilated ARDS patients. Intensive Care Med. 2014 Nov;40(11):1670-8. doi: 10.1007/s00134-014-3415-4. Epub 2014 Aug 12.
Results Reference
result
PubMed Identifier
19325511
Citation
Turner DA, Heitz D, Zurakowski D, Arnold JH. Automated measurement of the lower inflection point in a pediatric lung model. Pediatr Crit Care Med. 2009 Jul;10(4):511-6. doi: 10.1097/PCC.0b013e3181a0e274.
Results Reference
result
PubMed Identifier
32166264
Citation
Rosemeier I, Reiter K, Obermeier V, Wolf GK. Mechanical Ventilation Guided by Electrical Impedance Tomography in Children With Acute Lung Injury. Crit Care Explor. 2019 Jul 1;1(7):e0020. doi: 10.1097/CCE.0000000000000020. eCollection 2019 Jul.
Results Reference
result
PubMed Identifier
23255291
Citation
Cruces P, Donoso A, Valenzuela J, Diaz F. Respiratory and hemodynamic effects of a stepwise lung recruitment maneuver in pediatric ARDS: a feasibility study. Pediatr Pulmonol. 2013 Nov;48(11):1135-43. doi: 10.1002/ppul.22729. Epub 2012 Dec 19.
Results Reference
result
PubMed Identifier
25693014
Citation
Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
Results Reference
result
PubMed Identifier
30744430
Citation
Stapleton RD, Suratt BT, Neff MJ, Wurfel MM, Ware LB, Ruzinski JT, Caldwell E, Hallstrand TS, Parsons PE. Bronchoalveolar fluid and plasma inflammatory biomarkers in contemporary ARDS patients. Biomarkers. 2019 Jun;24(4):352-359. doi: 10.1080/1354750X.2019.1581840. Epub 2019 Mar 4.
Results Reference
result
Links:
URL
http://www.ardsnet.org/files/ventilator_protocol_2008-07.pdf
Description
National Heart, Lung, and Blood Institute ARDS Clinical Trials Network: Mechanical Ventilation Protocol Summary. 2008

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REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

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