Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 8:55 AM
Study NCT ID:
NCT05363332
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory drive', 'timeFrame': 'From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days', 'description': 'To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.'}], 'secondaryOutcomes': [{'measure': 'Cluster of high respiratory drive', 'timeFrame': 'From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days', 'description': 'To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms.'}, {'measure': 'Artificial intelligence algorithms', 'timeFrame': 'From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days', 'description': 'To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions.'}, {'measure': 'Neurocognitive disorders', 'timeFrame': '1 month after ICU discharge and 1 year after ICU discharge', 'description': 'To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.'}, {'measure': 'Gene expression', 'timeFrame': 'day 1 of ICU admission', 'description': 'Application of massive sequencing of gene expression and circulating micro-RNA in blood samples to identify sets of genes and c-miRNA whose quantified expression is related to ventilatory asynchronies and cognitive and emotional impairment in critically ill COVID-19 patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Critical Illness', 'Hypoxemic Respiratory Failure', 'Neurocognitive Dysfunction', 'Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge.\n\nThe investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients with hypoxemic respiratory failure.\n* Admitted to ICU.\n* Mechanical ventilation or high flow nasal cannula\n\nExclusion Criteria:\n\n* Neurologic patients with brainsteam affection.'}, 'identificationModule': {'nctId': 'NCT05363332', 'briefTitle': 'Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients With Acute Respiratory Failure Requiring High Flow Oxygen or Mechanical Ventilation: Mechanistic and Genomic Characterization Using Artificial Intelligence', 'orgStudyIdInfo': {'id': 'HighDrive COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Cohort', 'description': 'Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19.'}, {'label': 'Non COVID-19 Cohort', 'description': 'Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Candelaria De Haro, MD, PhD', 'role': 'CONTACT', 'email': 'cdeharo@tauli.cat', 'phone': '0034937231010', 'phoneExt': '21158'}, {'name': 'Josefina Lopez-Aguilar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Candelaria De Haro', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Manresa', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Fernandez, PhD', 'role': 'CONTACT', 'email': 'rfernandez@althaia.cat', 'phone': '938 75 93 00'}, {'name': 'Montserrat Batlle, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fundació Althaia', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Oviedo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Guilermo Muñiz-Albaiceta, PhD', 'role': 'CONTACT', 'email': 'gma@cri-lab.org', 'phone': '985 10 80 00'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Althaia Xarxa Assistencial Universitària de Manresa', 'class': 'OTHER'}, {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor and Doctor of Philosophy', 'investigatorFullName': 'Candelaria de Haro', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}