Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-25 @ 8:17 AM
Study NCT ID:
NCT04787666
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-05', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2/FiO2 more than 300', 'timeFrame': 'hospitalisation period, an average of 1 week', 'description': 'Comparison of PaO2/FiO2 before/after research'}], 'secondaryOutcomes': [{'measure': 'arterial blood oxygenation level', 'timeFrame': 'hospitalisation period, an average of 1 week', 'description': 'Comparison arterial blood oxygenation level before/after research'}, {'measure': 'maximum inspiratory volume', 'timeFrame': 'hospitalisation period, an average of 1 week', 'description': 'Comparison maximum inspiratory volume before/after research'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://intensive-care.ru/index.php/acc/article/view/433/2685', 'label': 'The article'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the effectiveness of three methods of non-invasive ventilation in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery', 'detailedDescription': 'The study includes the comparison of the three methods of non-invasive ventilation: non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and moderate respiratory failure in the early postoperative period after cardiac surgery. It assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to 60 years of age inclusive, with mild or moderate respiratory failure.The study will be randomized, single-center, prospective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age from 30 years to 60 years inclusive\n2. Decreased oxygenation function of the lungs (SpO2 less than 90%, PaO2/FiO2 less than 300, BH less than 25 per minute)\n3. By data CT/x-ray examination of hypoventilation zones (pneumonia, atelectasis)\n4. Consent the patient to participate in this study\n\nExclusion Criteria:\n\n1. Tracheal intubation, absence of independent breathing\n2. Unstable hemodynamics or hemodynamically significant rhythm disturbances\n3. Acute violation of the cerebral blood supply\n4. Shocks of various etiologies\n5. Impossibility provide respiratory protection , high risk of aspiration\n6. Lack of productive contact with the patient\n7. Patient's refusal to participate in this study"}, 'identificationModule': {'nctId': 'NCT04787666', 'briefTitle': 'Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Petrovsky National Research Centre of Surgery'}, 'officialTitle': 'Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure in the Postoperative Period After Cardiac Surgery', 'orgStudyIdInfo': {'id': '01092005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the first group: non-invasive mask ventilation', 'description': 'Dinamika of the indicator p/F Ratio', 'interventionNames': ['Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet']}, {'type': 'EXPERIMENTAL', 'label': 'the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)', 'description': 'Dinamika of the indicator p/F Ratio', 'interventionNames': ['Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet']}, {'type': 'EXPERIMENTAL', 'label': 'the third group:non-invasive ventilation with a helmet', 'description': 'Dinamika of the indicator p/F Ratio', 'interventionNames': ['Procedure: Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet']}], 'interventions': [{'name': 'Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet', 'type': 'PROCEDURE', 'description': 'Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet for tackling the problem of respiratory failure', 'armGroupLabels': ['the first group: non-invasive mask ventilation', 'the second group:high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation)', 'the third group:non-invasive ventilation with a helmet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Petrovsky Research National Centre of Surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexander A. Eremenko, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the Intensive Care Unit'}, {'name': 'Darya V. Ryabova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'anesthesiologist-resuscitator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Petrovsky National Research Centre of Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Russian national research center of surgery named after academian B. V. Petrovsky', 'investigatorFullName': 'Darya Ryabova, research worker', 'investigatorAffiliation': 'Petrovsky National Research Centre of Surgery'}}}}