Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07213518
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Velocity Nasal Insufflation Versus Continuous Positive Airway Pressure in COVID 19 Pneumonic Patients
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': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correction of hypoxia in COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure', 'timeFrame': '6 months', 'description': 'assessment of efficacy of High Velocity Nasal Insufflation versus Continuous Positive Airway Pressure in COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Velocity Nasal Insufflation', 'Acute Type 1 Respiratory Failure', 'COVID 19 Pneumonic Patients', 'Continuous Positive Airway Pressure'], 'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'compare the efficacy of High-Velocity Nasal Insufflation (HVNI) versus Continuous Positive Airway Pressure (CPAP) in managing COVID 19 pneumonic patients with acute type 1 respiratory failure', 'detailedDescription': 'A prospective randomized controlled trial was conducted on 108 patients with COVID 19 pneumonia with acute hypoxemic respiratory failure at Mansoura University Hospitals to compare the efficacy of High-Velocity Nasal Insufflation (HVNI) versus Continuous Positive Airway Pressure (CPAP) in managing COVID 19 pneumonic patients with acute type 1 respiratory failure, focusing on the need for invasive mechanical ventilation (IMV) and 28-day mortality. Patients were randomized into two equal groups: HVNI group and CPAP group. Baseline characteristics, respiratory parameters, and clinical outcomes were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged above 18 years with COVID 19 pneumonia with acute type 1 respiratory failure were included.\n\nExclusion Criteria:\n\n* patients with hypercapnic respiratory failure.\n* patients with a disturbed level of consciousness and/or a high risk of aspiration\n* individuals with hypotension\n* patients requiring invasive mechanical ventilation.'}, 'identificationModule': {'nctId': 'NCT07213518', 'briefTitle': 'High Velocity Nasal Insufflation Versus Continuous Positive Airway Pressure in COVID 19 Pneumonic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'High Velocity Nasal Insufflation Versus Continuous Positive Airway Pressure in COVID 19 Pneumonic Patients With Acute Type 1 Respiratory Failure', 'orgStudyIdInfo': {'id': 'MS.21.08.1614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Positive Airway Pressure', 'description': 'COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure received Continuous Positive Airway Pressure', 'interventionNames': ['Device: Continuous Positive Airway Pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Velocity Nasal Insufflation', 'description': 'COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure received High Velocity Nasal Insufflation', 'interventionNames': ['Device: High Velocity Nasal Insufflation']}], 'interventions': [{'name': 'High Velocity Nasal Insufflation', 'type': 'DEVICE', 'description': 'COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure received High Velocity Nasal Insufflation', 'armGroupLabels': ['High Velocity Nasal Insufflation']}, {'name': 'Continuous Positive Airway Pressure', 'type': 'DEVICE', 'description': 'COVID 19 Pneumonic Patients with Acute Type 1 Respiratory Failure received Continuous Positive Airway Pressure', 'armGroupLabels': ['Continuous Positive Airway Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mohamed AbdElmoniem', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed AbdElmoniem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of chest medicine faculty of medicine Mansoura university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}