Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 3:31 PM
Study NCT ID:
NCT07423520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D014474', 'term': 'Unconsciousness'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized crossover trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of lung collapse on cardiac output', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': "Evaluation of the relative contribution of lung collapse (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)"}, {'measure': 'Impact of lung collapse on pulmonary vascular resistance', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'Evaluation of the relative contribution of lung collapse (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\\^5) at different PEEP levels'}, {'measure': 'Impact of lung overdistention on cardiac output', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': "Evaluation of the relative contribution of lung overdistention (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)"}, {'measure': 'Impact of lung overdistention on pulmonary vascular resistance', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'Evaluation of the relative contribution of lung overdistention (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\\^5) at different PEEP levels'}], 'secondaryOutcomes': [{'measure': 'Correlation between potential for lung recruitment and PEEP-induced changes in cardiac output', 'timeFrame': 'Assessment at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP on cardiac output (mL/min) will be correlated through Pearson correlations with the individual potential for lung recruitment, as determined by the recruitment-to-inflation ratio (R/I)'}, {'measure': 'Correlation between potential for lung recruitment and PEEP-induced changes in pulmonary vascular resistance', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP on pulmonary vascular resistance (dyn·s/cm\\^5) will be correlated through Pearson correlations with the individual potential for lung recruitment, as determined by the recruitment-to-inflation ratio (R/I)'}, {'measure': 'PEEP-induced effects on cardiac output in cardiac preload responsive vs. nonresponsive patients', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP on cardiac output (L/min) will be compared through subgroup comparisons (student t-test) in patients who are preload responsive and patients who are not (preload responsiveness assessed through pulse-pressure variation, expressed in %)'}, {'measure': 'PEEP-induced effects on pulmonary vascular resistance in cardiac preload responsive vs. nonresponsive patients', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP on pulmonary vascular resistance (dyn·s/cm\\^5) will be compared through subgroup comparisons (student t-test) in patients who are preload responsive and patients who are not (preload resposnsiveness assessed through pulse-pressure variation, expressed in %)'}, {'measure': 'Relationship between transpulmonary pressures and central venous pressure variations', 'timeFrame': 'At the end of each of the three 30 minute steps', 'description': 'The relationship between transpulmonary pressure variations (cmH2O) and central venous pressure variations (cmH2O) between PEEP levels will be assessed through Pearson correlations'}, {'measure': 'Lung hysteresis', 'timeFrame': 'At the end of each of the three 30 minute steps', 'description': 'Lung hysteresis will be assessed at each of the tested PEEP levels and expressed as the area of the pressure-volume loop of the respiratory system obtained with a low-flow inflation/deflation maneuver from PEEP to a pressure of 30 cmH2O, in mL\\*cmH2O'}, {'measure': 'Lung aeration distribution', 'timeFrame': 'At the end of each of the three 30 minute steps', 'description': 'Lung aeration distribution at each PEEP level tested will be assessed with electrical impedance tomography (EIT) and expressed as dorsal fraction of ventilation (% of total tidal volume)'}, {'measure': 'Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in pulmonary vascular resistance', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP on pulmonary vascular resistance (dyn·s/cm\\^5) will be correlated through Pearson correlations with the individual PEEP-induced changes in lung volume (mL)'}, {'measure': 'Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in cardiac output', 'timeFrame': 'Assesment performed at the end of each of the three 30 minute steps', 'description': 'The effects of PEEP cardiac output (L/min) will be correlated through Pearson correlations with the individual PEEP-induced changes in lung volume (mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'AHRF', 'acute respiratory distress syndrome', 'PEEP', 'collapse', 'overdistention', 'hemodynamics', 'heart-lung interactions', 'mechanical ventilation', 'randomized crossover trial'], 'conditions': ['ARDS', 'AHRF']}, 'descriptionModule': {'briefSummary': "The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute respiratory failure with onset \\< 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;\n* bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses;\n* pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis;\n* PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;\n\nExclusion Criteria:\n\n* age \\<18 years;\n* pregnancy;\n* signs of barotrauma or documented pneumothorax;\n* severe tachycardia (HR \\> 120 bpm) and severe lacticaemia (lac \\> 4 mmol/L)\n* pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction \\< 35%);\n* contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);\n* intubation as a result of an acute exacerbation of chronic pulmonary disease;\n* contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).'}, 'identificationModule': {'nctId': 'NCT07423520', 'acronym': 'HI-FIVE', 'briefTitle': 'HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'HemodynamIc eFfects of Lung Collapse and overdIstension in Patients With Moderate-to-seVEre Acute Respiratory Distress Syndrome: the HI-FIVE Physiologic Study', 'orgStudyIdInfo': {'id': '7795'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung collapse and overdistention crossing point PEEP', 'interventionNames': ['Other: Change in PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'Low lung collapse PEEP', 'interventionNames': ['Other: Change in PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'Low lung overdistention PEEP', 'interventionNames': ['Other: Change in PEEP']}], 'interventions': [{'name': 'Change in PEEP', 'type': 'OTHER', 'description': 'Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps', 'armGroupLabels': ['Low lung collapse PEEP', 'Low lung overdistention PEEP', 'Lung collapse and overdistention crossing point PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Rome', 'country': 'Italy', 'contacts': [{'name': 'Domenico Luca Grieco, MD', 'role': 'CONTACT', 'email': 'dlgrieco@outlook.it', 'phone': '+393397681623'}, {'name': 'Massimo Antonelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tommaso Rosà, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Antonio Maria Dell'Anna, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simone Carelli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Filippo Bongiovanni, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A.Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Domenico Luca Grieco, MD', 'role': 'CONTACT', 'email': 'dlgrieco@outlook.it', 'phone': '+393397681623'}], 'overallOfficials': [{'name': 'Domenico Luca Grieco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'GRIECO DOMENICO LUCA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}