Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-04 @ 1:41 AM
Study NCT ID:
NCT06486259
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Assessment of the Risk of Lung Injury in Ventilated Patients
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of regional lung volume', 'timeFrame': '1 hour', 'description': 'comparison of regional lung volume in ml'}], 'secondaryOutcomes': [{'measure': 'comparison of regional volume of hyperinflated lung', 'timeFrame': '1 hour', 'description': 'comparison of regional volume of hyperinflated lung in ml'}, {'measure': 'comparison of regional lung deformation', 'timeFrame': '1 hour', 'description': 'comparison of regional lung deformation in percentage'}, {'measure': 'comparison of the amount of unstable lung', 'timeFrame': '1 hour', 'description': 'comparison of the amount of unstable lung in percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'VILI', 'Mechanical ventilation'], 'conditions': ['ARDS, Human']}, 'referencesModule': {'references': [{'pmid': '5508674', 'type': 'BACKGROUND', 'citation': 'Vinokurenko VM. [Dependence of dark adaptation on climatic factors]. Voen Med Zh. 1970 Dec;12:62-3. No abstract available. Russian.'}, {'pmid': '5537108', 'type': 'BACKGROUND', 'citation': 'Vallejo-Nagera JA. [New dimensions in the physician-patient relations]. An R Acad Nac Med (Madr). 1970;87(3):247-54. No abstract available. Spanish.'}, {'pmid': '3230208', 'type': 'BACKGROUND', 'citation': 'Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.'}, {'pmid': '9445314', 'type': 'BACKGROUND', 'citation': 'Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.'}, {'pmid': '10673186', 'type': 'BACKGROUND', 'citation': 'Hotchkiss JR Jr, Blanch L, Murias G, Adams AB, Olson DA, Wangensteen OD, Leo PH, Marini JJ. Effects of decreased respiratory frequency on ventilator-induced lung injury. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):463-8. doi: 10.1164/ajrccm.161.2.9811008.'}, {'pmid': '17392642', 'type': 'BACKGROUND', 'citation': 'Fujita Y, Fujino Y, Uchiyama A, Mashimo T, Nishimura M. High peak inspiratory flow can aggravate ventilator-induced lung injury in rabbits. Med Sci Monit. 2007 Apr;13(4):BR95-100.'}]}, 'descriptionModule': {'briefSummary': 'Specific characteristics of the lung, such as its functional capacity, heterogeneity, and recruitment potential, can influence the development of ventilator-induced lung injury even under safe ventilation conditions. Objective: To evaluate the risk of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated with similar tidal volumes and inspiratory pressures.', 'detailedDescription': "Mechanical ventilation constitutes a crucial resource serving as a bridge to pulmonary recovery in acute respiratory distress syndrome. However, like any medical intervention, it carries risks of adverse effects, both at the pulmonary and systemic levels. Mechanisms involved in the development of ventilator-induced lung injury include excessive stretching and deformation of lung tissues (stress/strain), cyclic opening and closing of alveoli causing shear stress (atelectrauma injury), and the resulting biological response to tissue damage (biotrauma).\n\nTo prevent and/or minimize the risk of ventilator-induced lung injury, monitoring of ventilatory mechanics seeks to understand the effects of the ventilatory cycle on the diseased lung. Factors such as tidal volume, plateau pressure, driving pressure, inspiratory flow, respiratory rate, excessive inspiratory effort, and occasionally positive end-expiratory pressure have been directly associated with the mechanism of damage. From an integrative perspective, the concept of mechanical power seeks to encompass most of these factors within a measurable unit thus expressing the energy repeatedly applied to the respiratory system over a unit of time. Mechanical power provides a more comprehensive view of the burden imposed on the lung and can assist in the identification and management of potential risks associated with mechanical ventilation.\n\nHowever, mechanical power is not the only factor involved in the development of VILI, as factors such as the duration of mechanical ventilation and the conditions specific to the diseased lung also play a role.ventilator-induced lung injury results from the relationship between the load imposed by the ventilator and the inability of the lung parenchyma to tolerate it. Factors such as reduced lung functional capacity, heterogeneity of aeration loss, and instability of collapsed alveoli, among others, can modulate the lung's tolerance to mechanical injury and influence the development of ventilator-induced lung injury . Finally, different regional lung conditions may give rise to the coexistence of different injury mechanisms in the same lung.\n\nObjective: To evaluate different mechanisms of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated in the supine position with similar lung load."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: ARDS patients\n\n\\-\n\nExclusion Criteria:Patients with any of the following criteria were excluded:\n\n* History of emphysema, asthma, pneumothorax, or active bronchopulmonary fistula.\n* Severe instability at the time of the study defined by at least one of the following indicators: SaO2 ≤ 90%, shock requiring \\> 0.5 γ/kg/min of noradrenaline, complex arrhythmia, myocardial ischemia, intracranial hypertension refractory despite first-line measures.\n* Esophageal pathology contraindicating esophageal balloon placement (esophageal varices, stenosis, trauma or esophageal surgery, tumor) and/or hematemesis.\n* Severe coagulopathy (platelet count \\<20,000/mm3 or INR \\>4.\n* Inability to undergo computed tomography: morbid obesity (\\>170 kg) or abdominal circumference \\>200 cm.\n* Patients with do-not-resuscitate orders and pregnant women.\n* Participation in another research study in the last 30 days.'}, 'identificationModule': {'nctId': 'NCT06486259', 'acronym': 'RLY', 'briefTitle': 'Regional Assessment of the Risk of Lung Injury in Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital El Cruce'}, 'officialTitle': 'Regional Assessment of the Risk of Lung Injury in Ventilated Patients With Similar Lung Load', 'orgStudyIdInfo': {'id': 'EL CRUCE HOSPITAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ventral', 'description': 'Ventral half of the lung\n\n..', 'interventionNames': ['Other: Controlled mechanical ventilation']}, {'label': 'Dorsal', 'description': 'Dorsal half of the lung', 'interventionNames': ['Other: Controlled mechanical ventilation']}], 'interventions': [{'name': 'Controlled mechanical ventilation', 'type': 'OTHER', 'description': 'Patients were ventilated under similar tidal volume, respiratory rate, and plateau pressure. PEEP was the adjustment variable to reach a similar plateau pressure', 'armGroupLabels': ['Dorsal', 'ventral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1853', 'city': 'San Juan Bautista', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Nestor Pistillo, MD', 'role': 'CONTACT', 'email': 'nestor.pistillo@hospitalelcruce.org', 'phone': '01134367989'}, {'name': 'Osvaldo Fariña', 'role': 'CONTACT', 'email': 'osvaldo.fariña@hospitalelcruce.org', 'phone': '01140524299'}], 'facility': 'Hospital El Cruce', 'geoPoint': {'lat': -34.80896, 'lon': -58.27623}}], 'centralContacts': [{'name': 'Nestor Pistillo, MD', 'role': 'CONTACT', 'email': 'nestor.pistillo@hospitalelcruce.org', 'phone': '01134367989'}, {'name': 'Osvaldo Fariña, MD', 'role': 'CONTACT', 'email': 'osvaldo.fariña@hospitalelcruce.org', 'phone': '01140524299'}], 'overallOfficials': [{'name': 'Nestor Pistillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital El Cruce', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nestor Pistillo', 'investigatorAffiliation': 'Hospital El Cruce'}}}}