Clinical trial NCT06067152: REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS
Official title: REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS
Pediatric Respiratory Distress Syndrome
Respiratory Disease
Keywords: Non invasive ventilation
electrical impedance tomography;
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Regional Ventilation Delay, RDV (pixels %), at T2 and T0
timeFrame: 1 day
Secondary outcomes:
measure: Differences in Tidal Impedance Distribution,TID (pixels %), at T0, T1 and T2
timeFrame: 1 day
measure: Gravity Centre, GC, differences (pixels %) at T0, T1 and T2
timeFrame: 1 day
measure: Respiratory Rate at T0, T1 and T2
timeFrame: 1 day
measure: FiO2 (%) at T0, T1 and T2
timeFrame: 1 day
measure: Respiratory compliance at T0, T1 and T2
timeFrame: 1 day
measure: Lung compliance at T0, T1 and T2
timeFrame: 1 day
measure: Chest Wall compliance at T0, T1 and T2
timeFrame: 1 day
measure: S/F ratio at T0, T1 and T2
timeFrame: 1 day
measure: Sistolic Blood Pressure at T0, T1 and T2
timeFrame: 1 day
measure: Diastolic Blood Pressure at T0, T1 and T2
timeFrame: 1 day
measure: pH at T0, T1 and T2
timeFrame: 1 day
measure: SpO2 at T0, T1 and T2
timeFrame: 1 day
measure: PaO2 at T0, T1 and T2
timeFrame: 1 day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Giovanna Chidini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.