Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT04741659
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], '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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2021-02-01', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'respiratory pattern', 'timeFrame': '30 minutes', 'description': 'the way the patient is breathing recorded by respiratory inductance plethysmography (RIP)'}, {'measure': 'respiratory mechanics', 'timeFrame': '30 minutes', 'description': 'the inspiratory effort of the patient recorded by esophageal pressure'}], 'secondaryOutcomes': [{'measure': 'changes in Arterial Blood Gases (ABGs)', 'timeFrame': 'immediately after intervention', 'description': 'Arterial Blood Gases, namely arterial oxygen (PaO2) and carbon dioxyde (PaCO2) tension will be analyzed from a sample taken from the arterial artery'}, {'measure': 'Dyspnea score', 'timeFrame': 'immediately after intervention', 'description': 'Dyspnea will be recorded using the Borg scale that is a numeric scale where 0 is no dyspnea and 10 the maximal dyspnea that a patient can imagine'}, {'measure': 'Comfort score', 'timeFrame': 'immediately after intervention', 'description': 'this will be assessed using a dedicated visual analog scale (VAS with a length of 20 cm)'}, {'measure': 'Blood pressure (BP) and Heart rate (HR) measurements', 'timeFrame': '30 minutes', 'description': 'blood pressure and heart rate will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['De novo', 'ARF'], 'conditions': ['Acute Hypoxemic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients.\n\nThe aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Respiratory Failure (ARF) ( 100 \\<PaO2/FiO2 \\<300) due to Covid-19 infection\n* Informed consent\n* Enrollment within the first 24 hours after ARF\n\nExclusion Criteria:\n\n* Clinical, radiological or istological evidence of chronic pulmonary disease.\n* Body Mass Index (BMI) \\> 30 kg/m2;\n* Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)\n* Chest wall disease\n* Heart failure\n* Severe hemodynamic instability ( need for amine support)\n* Acute coronary syndrome (ACS)\n* Severe arrhythmia\n* Patients unable to protect respiratory airways\n* Respiratory arrest and need for endotracheal intubation\n* Pregnancy\n* Need for sedation\n* Home long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT04741659', 'acronym': 'DENOVT', 'briefTitle': 'Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study', 'orgStudyIdInfo': {'id': '691/2020/Sper/AOUBo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'spontaneous breathing trial', 'description': 'the patients will be asked to breathe spontaneously using their actual low oxygen flow', 'interventionNames': ['Device: Ventimask', 'Device: High Flow Nasal cannula (HFNC)', 'Device: Helmet CPAP', 'Device: Non Invasive Ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Flow Nasal cannula (HFNC)', 'description': 'The patients will be asked to breathe with HFNC of 40 L/min', 'interventionNames': ['Device: Ventimask', 'Device: High Flow Nasal cannula (HFNC)', 'Device: Helmet CPAP', 'Device: Non Invasive Ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Helmet CPAP', 'description': 'the patients will be asked to breathe with the Helmet CPAP', 'interventionNames': ['Device: Ventimask', 'Device: High Flow Nasal cannula (HFNC)', 'Device: Helmet CPAP', 'Device: Non Invasive Ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non Invasive Ventilation (NIV)', 'description': 'the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface', 'interventionNames': ['Device: Ventimask', 'Device: High Flow Nasal cannula (HFNC)', 'Device: Helmet CPAP', 'Device: Non Invasive Ventilation (NIV)']}], 'interventions': [{'name': 'Ventimask', 'type': 'DEVICE', 'description': 'The patients will be asked to breathe spontaneously using their actual low oxygen flow', 'armGroupLabels': ['Helmet CPAP', 'High Flow Nasal cannula (HFNC)', 'Non Invasive Ventilation (NIV)', 'spontaneous breathing trial']}, {'name': 'High Flow Nasal cannula (HFNC)', 'type': 'DEVICE', 'description': "The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values \\>/= 92%", 'armGroupLabels': ['Helmet CPAP', 'High Flow Nasal cannula (HFNC)', 'Non Invasive Ventilation (NIV)', 'spontaneous breathing trial']}, {'name': 'Helmet CPAP', 'type': 'DEVICE', 'description': 'The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values \\>/= 92%', 'armGroupLabels': ['Helmet CPAP', 'High Flow Nasal cannula (HFNC)', 'Non Invasive Ventilation (NIV)', 'spontaneous breathing trial']}, {'name': 'Non Invasive Ventilation (NIV)', 'type': 'DEVICE', 'description': 'the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface', 'armGroupLabels': ['Helmet CPAP', 'High Flow Nasal cannula (HFNC)', 'Non Invasive Ventilation (NIV)', 'spontaneous breathing trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': "IRCCS Policlinico di Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Stefano Nava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Stefano Nava, Professor of Respiratory Medicine/ Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ S.Orsola-Malpighi University Hospital, Bologna (IT)', 'investigatorFullName': 'dr. Stefano Nava', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}