Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 3:09 AM
Study NCT ID:
NCT05467332
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HFNC-PEEP', 'timeFrame': '3 HOURS', 'description': 'THE LEVEL OF POSITIVE AIRWAY PRESSURE GENERATED BY DIFFERENT FLOW RATES OX OXYGEN WILL BE RECORDED.\n\nFLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN.'}], 'secondaryOutcomes': [{'measure': 'HFNC-EADI', 'timeFrame': '3 HOURS', 'description': 'ELECTRICAL ACTIVITY OF THE DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE DURING ALL THE PROCESS.\n\nFLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care unit, critically ill patient, high flow nasal cannula, PEEP, respiratory failure, non invasive ventilation'], 'conditions': ['Acute Respiratory Failure', 'High Flow Nasal Cannula', 'Critically Ill', 'Airway Disease', 'Positive End Expiratory Pressure', 'Diaphragm Disease']}, 'descriptionModule': {'briefSummary': 'High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation.\n\nIt acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients.\n\nHowever to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients.\n\nThe primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CRITICALLY ILL PATIENTS REQUIRING INVASIVE MECHANICAL VENTILATION FOR AT LEAST 72 HOURS AND READY FOR EXTUBATION.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: CRITICALLY ILL PATIENTS AFTER MECHANICAL VENTILATION LASTED AT LEAST 72 HOURS\n\n* age 18-80 years\n\nExclusion Criteria:\n\n* COPD stage \\>1 according to GOLD classification\n* end stage organ disease (liver, kidney, heart, lung)\n* neuromuscular disease\n* neoplasm\n* previous tracheostomy\n* obesity with BMI \\> 35 Kg/m2\n* non collaborative patient'}, 'identificationModule': {'nctId': 'NCT05467332', 'acronym': 'HPEEP', 'briefTitle': 'Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': 'Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.', 'orgStudyIdInfo': {'id': 'HPEEP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRITICALLY ILL PATIENTS', 'description': 'CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED.', 'interventionNames': ['Device: HIGH FLOW NASAL OXYGEN']}], 'interventions': [{'name': 'HIGH FLOW NASAL OXYGEN', 'type': 'DEVICE', 'otherNames': ['AIRVO2, FISHER&PAYKEL'], 'description': "BEFORE EXTUBATION, AN AIRWAY EXCHANGE CATHETER (AEC) WILL BE PUT INTO THE PATIENTS' TRACHEA AND IT WILL REMAIN IN SITE AFTER EXTUBATION. THROUGH AN AEC CONNECTED TO A PRESSURE MONITOR, IT WILL BE RECORDED TRACHEAL PRESSURE DURING SPONTANEOUSLY BREATHING PATIENT AT DIFFERENT FLOW RATES OF HFNC THAT WILL BE APPLIED JUST AFTER EXTUBATION.\n\nMEANWHILE, VITAL PARAMETERS RECORDED WITH A MULTIPARAMETRIC MONITOR WILL BE RECORDED.\n\nFINALLY, MONITORING OF ELECTRICAL ACTIVITY OF DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE TO EVALUATE IT AT DIFFERENT FLOW RATES.", 'armGroupLabels': ['CRITICALLY ILL PATIENTS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Cristian Deana', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Cristian Deana, MD', 'role': 'CONTACT', 'email': 'cristian.deana@asufc.sanita.fvg.it', 'phone': '+390432552410'}], 'overallOfficials': [{'name': 'Cristian Deana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Anesthesiologist and Critical Care Physician', 'investigatorFullName': 'Cristian Deana', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}