Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-09 @ 11:47 PM
Study NCT ID:
NCT03133520
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation rate', 'timeFrame': 'First seven days', 'description': 'Intubation rate for each group'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'First 28 days', 'description': 'All-cause day-28 mortality'}, {'measure': 'patients comforts', 'timeFrame': 'First 24 hours', 'description': 'Patient comfort with Visual Analogue Scale (VAS) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory failure', 'immuncompromise patients', 'high flow oxygen'], 'conditions': ['Acute Hypoxemic Respiratory Failure', 'Hematologic Malignancy']}, 'referencesModule': {'references': [{'pmid': '23321772', 'type': 'BACKGROUND', 'citation': 'Turkoglu M, Erdem GU, Suyani E, Sancar ME, Yalcin MM, Aygencel G, Aki Z, Sucak G. Acute respiratory distress syndrome in patients with hematological malignancies. Hematology. 2013 May;18(3):123-30. doi: 10.1179/1607845412Y.0000000038. Epub 2012 Nov 15.'}, {'pmid': '26521922', 'type': 'BACKGROUND', 'citation': 'Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.'}, {'pmid': '25003980', 'type': 'BACKGROUND', 'citation': 'Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.'}, {'pmid': '26975498', 'type': 'BACKGROUND', 'citation': 'Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.'}]}, 'descriptionModule': {'briefSummary': 'Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure', 'detailedDescription': 'Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.\n\nHigh-flow nasal oxygen \\[HFNO\\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \\[of up to 60 L/min\\] via nasal cannula devices, with fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.\n\nClinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.\n\nThus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known immunosuppression defined as haematological malignancy.\n* Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2\\<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2\\<92%\n* Respiratory distress with a respiratory rate \\>22/min\n\nExclusion Criteria:\n\n* Refusal of study participation\n* Pregnancy or breastfeeding\n* Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)\n* Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)\n* Haemodynamic instability (mean arterial pressure \\<65 mmHg)\n* Vasopressor needs\n* Awareness confusion and disorientation'}, 'identificationModule': {'nctId': 'NCT03133520', 'acronym': 'HFOT', 'briefTitle': 'Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure', 'orgStudyIdInfo': {'id': 'November, 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard oxygen group', 'description': 'This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.'}, {'type': 'EXPERIMENTAL', 'label': 'High flow oxygen therapy group', 'description': 'This patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it allows the delivery of higher flow rates \\[of up to 60 L/min\\] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.', 'interventionNames': ['Device: High flow oxygen therapy']}], 'interventions': [{'name': 'High flow oxygen therapy', 'type': 'DEVICE', 'description': 'High-flow nasal oxygen \\[HFNO\\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \\[of up to 60 L/min\\] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.', 'armGroupLabels': ['High flow oxygen therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Medical School', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kursat Gundogan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Kursat Gundogan', 'investigatorAffiliation': 'TC Erciyes University'}}}}