REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

ARDS Clinical Trial

— REMAV-EIT  

Official title:

REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in Pediatric Acute Respiratory Distress Syndrome (pARDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067152
• Other study ID #: REMAV-EIT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: August 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Giovanna Chidini, MD
• Phone: 0255032242
• Email: giovanna.chidini[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• ARDS
• Respiration Disorders
• Respiratory Disease
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Diseases
• Syndrome

Intervention

Device:
• EIT measurement
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 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 ventilation
Mechanical ventilation is set according to EIT measurement
• Reevaluation after 24 h
Evaluation of mechanical ventilation and ventilation distribution through EIT after 24h of ventilation EIT-guided

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (23)

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 sy — View 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):74 — View 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 i — View 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 — View 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 — View 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. — View 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/NEJMoa052 — View 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 — View 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, Girar — View 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 — View 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-managemen — View 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 r — View 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.0000 — View 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 saf — View 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. — View 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. 201 — View 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.201 — View 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. — View 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 M — View 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/ — View 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: 1 — View 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 lun — View 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. Ep — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional Ventilation Delay, RDV (pixels %), at T2 and T0	RDV is an index of atelectrauma, supra-distention and in general an inhomogeneous ventilation	1 day
Secondary	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	1 day
Secondary	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	1 day
Secondary	Respiratory Rate at T0, T1 and T2	Respiratory rate (breaths/min)	1 day
Secondary	FiO2 (%) at T0, T1 and T2	FiO2 (%)	1 day
Secondary	Respiratory compliance at T0, T1 and T2	Respiratory System Compliance	1 day
Secondary	Lung compliance at T0, T1 and T2	Clung Lung compliance	1 day
Secondary	Chest Wall compliance at T0, T1 and T2	Chest Wall compliance	1 day
Secondary	S/F ratio at T0, T1 and T2	S/F ratio	1 day
Secondary	Sistolic Blood Pressure at T0, T1 and T2	SBP (mmHg)	1 day
Secondary	Diastolic Blood Pressure at T0, T1 and T2	DBP (mmHg)	1 day
Secondary	pH at T0, T1 and T2	pH	1 day
Secondary	SpO2 at T0, T1 and T2	SpO2 (%)	1 day
Secondary	PaO2 at T0, T1 and T2	PaO2 (mmHg)	1 day

External Links

•   National Heart, Lung, and Blood Institute ARDS Clinical Trials Network: Mechanical Ventilation Protocol Summary. 2008