Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04005092
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D006940', 'term': 'Hyperemia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-31', 'size': 39191, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-08T00:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-18', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': '1 hour', 'description': 'Respiratory rate reduction post intervention'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '1 hour', 'description': 'Heart rate reduction post intervention'}, {'measure': 'Partial Pressure Of Arterial Oxygen Level', 'timeFrame': '1 hour', 'description': 'Partial arterial oxygen level post intervention'}, {'measure': 'Ratio Of Partial Pressure Arterial Oxygen And Fraction Of Oxygen', 'timeFrame': '1 hour', 'description': 'Partial arterial oxygen/fraction of oxygen ratio improvement post intervention'}, {'measure': 'Dyspnoea Scale', 'timeFrame': '1 hour', 'description': 'Dyspnoea scale improvement post intervention.Dyspnea scale measured using an unmarked 10cm VAS card that had mark with "I can breathe normally", at one end correspond to patients\' normal baseline breathing which score "0" and on the other end "I can\'t breathe at all", which score "10" represent the worst difficulty perceived by patients.'}, {'measure': 'Heart Rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) And Respiratory Rate(HACOR) Score', 'timeFrame': '1 hour', 'description': 'Heart rate,Acidosis (pH), Consciousness (GCS), Oxygenation (PF ratio) and Respiratory rate(HACOR) Score improvement post intervention.HACOR is an acronym for heart rate, acidosis (pH), consciousness (GCS), oxygenation (PF ratio) and respiratory rate in which each parameter is an independent predictor for NIV failure. HACOR score is out of 25 with differential weighting of each parameter.'}, {'measure': 'Rate Of Intubation', 'timeFrame': '1 hour', 'description': 'Intubation rate post intervention'}, {'measure': '28-Days Mortality In Acute Cardiogenic Pulmonary Edema', 'timeFrame': '28 days', 'description': 'Mortality due to Acute Cardiogenic Pulmonary Edema'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non invasive ventilation', 'pulmonary edema', 'high flow nasal cannula', 'helmet CPAP', 'respiratory failure', 'hyperaemia'], 'conditions': ['Cardiogenic Pulmonary Edema']}, 'referencesModule': {'references': [{'pmid': '34632507', 'type': 'DERIVED', 'citation': 'Osman A, Via G, Sallehuddin RM, Ahmad AH, Fei SK, Azil A, Mojoli F, Fong CP, Tavazzi G. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1103-1111. doi: 10.1093/ehjacc/zuab078.'}]}, 'descriptionModule': {'briefSummary': 'This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Oedema (ACPE) patients in the Emergency Department (ED) delivered by Helmet CPAP (hCPAP) and HFNC.Patients will be randomized to receive either hCPAP or HFNC.', 'detailedDescription': 'Non-invasive ventilation(NIV) has different types of interfaces that had been used in acute hypoxaemic and hypercapnic respiratory failure. The appropriate interface is necessary to provide comfort and lead to the success of NIV.\n\nHelmet continuous positive airway pressure (hCPAP) is an NIV interface that allows the provision of high airway pressures with a minimal leak.\n\nHFNC which delivers heated humidified high flow oxygen provides a good alternative to the conventional NIV in terms of comfort'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema.\n\nExclusion Criteria:\n\n1. Age less than 18 years old\n2. Low GCS (less than 8), altered mental status\n3. Hemodynamic instability, impending cardiopulmonary arrest\n4. Use of vasopressors, inotropes\n5. Exacerbation of asthma or chronic respiratory failure\n6. Urgent need for endotracheal intubation\n7. Absence of airway protective gag reflex\n8. Elevated intracranial pressure\n9. Tracheostomy\n10. Pregnant\n11. Upper airway obstruction\n12. Injuries or surgery to head and neck less than 6 months upon presentation\n13. Claustrophobia\n14. Blind or poor vision\n15. Medico-legal related cases'}, 'identificationModule': {'nctId': 'NCT04005092', 'acronym': 'HCPAPvsHFNC', 'briefTitle': 'Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Raja Permaisuri Bainun'}, 'officialTitle': 'Helmet Continuous Positive Airway Pressure Versus High Flow Nasal Cannula Oxygen in Acute Cardiogenic Pulmonary Oedema: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'NMRR-17-1839-36966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Helmet Continuous Positive Airway Pressure(hCPAP)', 'description': 'Helmet CPAP produce a better physiological outcomes after 1-hour intervention', 'interventionNames': ['Device: hCPAP versus HFNC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Flow Nasal Cannula(HFNC)', 'description': 'HFNC produce a better physiological outcomes after 1-hour intervention', 'interventionNames': ['Device: hCPAP versus HFNC']}], 'interventions': [{'name': 'hCPAP versus HFNC', 'type': 'DEVICE', 'description': 'The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.', 'armGroupLabels': ['Helmet Continuous Positive Airway Pressure(hCPAP)', 'High Flow Nasal Cannula(HFNC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30450', 'city': 'Ipoh', 'state': 'Perak', 'country': 'Malaysia', 'facility': 'Emergency Department, Hospital Raja Permaisuri Bainun', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}], 'overallOfficials': [{'name': 'ADI OSMAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EMERGENCY DEPARTMENT, HOSPITAL RAJA PERMAISURI BAINUN, IPOH, PERAK, MALAYSIA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Raja Permaisuri Bainun', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EMERGENCY MEDICINE CONSULTANT', 'investigatorFullName': 'Dr. Adi Bin Osman', 'investigatorAffiliation': 'Hospital Raja Permaisuri Bainun'}}}}