Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-31 @ 12:10 AM
Study NCT ID:
NCT04460859
Status:
RECRUITING
Last Update Posted:
2025-05-20
First Post:
2020-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RecruitmEnt Assessed by eleCtRical Impedance Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential for lung recruitment', 'timeFrame': '2 hours', 'description': 'The potential for lung recruitment will be assessed with EIT. Several methods will be used and compared, based on e.g. pixel information of lung aeration, and pressure-volume characteristics at different PEEP steps.'}], 'secondaryOutcomes': [{'measure': 'Recruitment-to-inflation (R/I) ratio', 'timeFrame': '2 hours'}, {'measure': 'EIT-based optimum PEEP level', 'timeFrame': '2 hours'}, {'measure': 'PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O', 'timeFrame': '2 hours', 'description': 'For those patients with esophageal pressure measurements available'}, {'measure': 'Organ dysfunction as per the sequential organ failure assessment (SOFA) score', 'timeFrame': 'Day 1, 3, 7', 'description': 'SOFA score min-max: 0-24; a higher score is associated with poor prognosis.'}, {'measure': 'Vital status at ICU discharge, 28 days, and hospital discharge', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'Vital status (death/alive) will be assessed via chart review'}, {'measure': 'Ventilator free days', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mechanical Ventilation', 'Lung recruitment', 'ARDS', 'Electrical impedance tomography'], 'conditions': ['Acute Respiratory Distress Syndrome (ARDS)']}, 'referencesModule': {'references': [{'pmid': '31577153', 'type': 'BACKGROUND', 'citation': 'Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.'}, {'pmid': '19255741', 'type': 'BACKGROUND', 'citation': 'Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.'}, {'pmid': '27596161', 'type': 'BACKGROUND', 'citation': 'Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.'}, {'pmid': '37097986', 'type': 'DERIVED', 'citation': 'Jonkman AH, Alcala GC, Pavlovsky B, Roca O, Spadaro S, Scaramuzzo G, Chen L, Dianti J, Sousa MLA, Sklar MC, Piraino T, Ge H, Chen GQ, Zhou JX, Li J, Goligher EC, Costa E, Mancebo J, Mauri T, Amato M, Brochard LJ; Pleural Pressure Working Group (PLUG). Lung Recruitment Assessed by Electrical Impedance Tomography (RECRUIT): A Multicenter Study of COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2023 Jul 1;208(1):25-38. doi: 10.1164/rccm.202212-2300OC.'}, {'pmid': '36192569', 'type': 'DERIVED', 'citation': 'Otahal M, Mlcek M, Borges JB, Alcala GC, Hladik D, Kuriscak E, Tejkl L, Amato M, Kittnar O. Prone positioning may increase lung overdistension in COVID-19-induced ARDS. Sci Rep. 2022 Oct 3;12(1):16528. doi: 10.1038/s41598-022-20881-6.'}, {'pmid': '33894747', 'type': 'DERIVED', 'citation': 'Mlcek M, Otahal M, Borges JB, Alcala GC, Hladik D, Kuriscak E, Tejkl L, Amato M, Kittnar O. Targeted lateral positioning decreases lung collapse and overdistension in COVID-19-associated ARDS. BMC Pulm Med. 2021 Apr 24;21(1):133. doi: 10.1186/s12890-021-01501-x.'}], 'seeAlsoLinks': [{'url': 'https://www.plugwgroup.org', 'label': 'Website of the PLUG working group'}]}, 'descriptionModule': {'briefSummary': 'The RECRUIT study is a multinational, multicenter physiological observational study conducted by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography (EIT).', 'detailedDescription': 'Despite higher positive end-expiratory pressure (PEEP) being associated with multiple physiologic benefits, randomized clinical trials comparing higher vs. lower PEEP levels failed to show improved survival of ARDS patients. Higher PEEP should fully exploit its benefits only when implemented in patients with higher potential for alveolar recruitment (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with airway closure. Retrospective analysis of randomised clinical trials with PEEP suggests that when high PEEP is used in responders (oxygenation), survival may be better. Conversely, in the absence of significant recruitment, higher PEEP should be avoided and lower PEEP might be recommended.\n\nTitration of PEEP provided by the mechanical ventilator in patients with severe lung injury should thus be based on bedside information on lung recruitability. However, no valid method exists to define the best PEEP to optimize recruitment and minimize lung overdistention. Recruitability varies and is often not assessed. Electrical impedance tomography (EIT) is a non-invasive bedside imaging technique for measuring the potential for lung recruitment in ARDS patients. By performing lung (de)recruitment maneuvers and in-depth analyses, we will define lung recruitability indices and develop methods for real-time and personalized PEEP selection. This study will prove the feasibility of minimizing risks associated with inadequate mechanical ventilation by EIT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intubated mechanically ventilated patients will be considered for enrolment in the first week of ARDS diagnosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \\<= 200 mmHg)\n* Under continuous sedation with or without paralysis\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Bronchopleural fistula\n* Pure COPD exacerbation\n* Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)\n* Hemodynamic instability (Systolic BP \\< 75 mmHg or MAP \\< 60 mmHg despite vasopressors and/or heart rate \\< 55 bpm)\n* Attending physician deems the transient application of high airway pressures to be unsafe'}, 'identificationModule': {'nctId': 'NCT04460859', 'acronym': 'RECRUIT', 'briefTitle': 'RecruitmEnt Assessed by eleCtRical Impedance Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.', 'orgStudyIdInfo': {'id': '2027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intubated mechanically ventilated ARDS patients', 'description': 'Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition', 'interventionNames': ['Other: Specific lung recruitment maneuvers']}], 'interventions': [{'name': 'Specific lung recruitment maneuvers', 'type': 'OTHER', 'description': 'Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.', 'armGroupLabels': ['Intubated mechanically ventilated ARDS patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marcelo Amato, MD', 'role': 'CONTACT', 'email': 'marcelo.amato@fm.usp.br'}], 'facility': 'Faculdade de Medicina da University São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M5B1T8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Laurent Brochard, MD', 'role': 'CONTACT', 'email': 'Laurent.Brochard@unityhealth.to', 'phone': '416-864-6060', 'phoneExt': '5686'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Mauri, MD', 'role': 'CONTACT', 'email': 'tommaso.mauri@unimi.it'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Oriol Roca, MD', 'role': 'CONTACT', 'email': 'oroca@vhebron.net'}], 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Laurent Brochard, MD', 'role': 'CONTACT', 'email': 'Laurent.Brochard@unityhealth.to', 'phone': '416-864-5686', 'phoneExt': '5686'}], 'overallOfficials': [{'name': 'Laurent Brochard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}