Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06716502
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Portable Device for Non-invasive Ventilatory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-28', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device easiness-to-use', 'timeFrame': 'Up to 2 hours', 'description': 'Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation.\n\nA semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.'}, {'measure': 'Duration of proper pressure delivery', 'timeFrame': 'Up to 2 hours', 'description': 'Total time of target pressure (4 - 15 cmH2O) during 15-min test'}, {'measure': 'Battery power consumption and duration', 'timeFrame': 'Up to 2 hours', 'description': 'We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.'}, {'measure': 'Change in SpO2 level', 'timeFrame': 'Up to 2 hours', 'description': 'Change in SpO2 before and during the device application'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CPAP', 'NIV', 'Respiratory failure'], 'conditions': ['Healthy', 'Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.\n\nThe efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.', 'detailedDescription': 'The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Arm 1\n\nInclusion Criteria:\n\n1. Age ≥65 years\n2. Clinically stable: non-hospitalized and not in acute illness\n3. no professional medical knowledge: no experience as a health care provider\n4. Ability to express informed consent as requested by the ethical committee\n\nArm 1 Exclusion Criteria: none\n\nArm 2\n\nInclusion Criteria:\n\n1. Hospitalized adult patient\n2. SpO2 of 90-93% in room air\n\nArm 2\n\nExclusion Criteria:\n\n1. Facial burns/trauma/recent facial or upper airway surgery\n2. Vomiting\n3. Fixed upper airway obstruction\n4. Undrained pneumothorax\n5. Recent upper gastrointestinal surgery\n6. Inability to protect the airway\n7. Bowel obstruction\n8. Patient refusal'}, 'identificationModule': {'nctId': 'NCT06716502', 'acronym': 'PREVENT', 'briefTitle': 'A New Portable Device for Non-invasive Ventilatory Support', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'PNRR-POC-2022-12376704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy elderly individuals', 'description': "The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device.", 'interventionNames': ['Device: Portable CPAP usability assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with mild oxygenation impairment', 'description': 'The efficacy of the device will be assessed in patients with mild oxygenation impairment.', 'interventionNames': ['Device: Portable CPAP efficacy']}], 'interventions': [{'name': 'Portable CPAP efficacy', 'type': 'DEVICE', 'description': 'The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O', 'armGroupLabels': ['Patients with mild oxygenation impairment']}, {'name': 'Portable CPAP usability assessment', 'type': 'DEVICE', 'description': "The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.", 'armGroupLabels': ['Healthy elderly individuals']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lecce', 'state': 'Apulia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Santarpino, MD', 'role': 'CONTACT'}], 'facility': 'Città di Lecce Hospital', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Landoni, MD', 'role': 'CONTACT', 'email': 'landoni.giovanni@hsr.it'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Katia Donadello, MD', 'role': 'CONTACT'}], 'facility': 'Università degli studi di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Giovanni Landoni, MD', 'role': 'CONTACT', 'email': 'landoni.giovanni@hsr.it', 'phone': '+39 022643', 'phoneExt': '6151'}, {'name': 'Rosalba Lembo', 'role': 'CONTACT', 'email': 'lembo.rosalba@hsr.it', 'phone': '+39 022643', 'phoneExt': '6151'}], 'overallOfficials': [{'name': 'Giovanni Landoni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, {'name': 'Città di Lecce Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Research Center for Intensive Care and Anesthesiology of San Raffaele Scientific Institute', 'investigatorFullName': 'Giovanni Landoni', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}