Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-26 @ 2:18 PM
Study NCT ID:
NCT04824703
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stroke volume in milliliters', 'timeFrame': 'Change from Baseline stroke volume At ICU admission and through study completion An average 6 months', 'description': 'Volume of blood in milliliters that is ejected from heart each second and measured By Echocardiography'}, {'measure': 'Change in ejection fraction of heart in percentage', 'timeFrame': 'Change from baseline ejection fraction at icu admission and through study completion An Average 6 months', 'description': "percentage of blood that's pumped out of a filled ventricle with each heartbeat And measured by echocardiography"}], 'secondaryOutcomes': [{'measure': 'Acute respiratory distress syndrome', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Acute persistent hypoxia with bilateral lung infiltrate due to non cardiac cause'}, {'measure': 'Sepsis', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Systolic blood pressure \\< 90 Respiratory rate \\> 22 Heart rate \\> 100'}, {'measure': 'Stroke', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Cerebrovascular accidents'}, {'measure': 'Mechanical Ventilator free days', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Days without mechanical ventilation'}, {'measure': 'Shock', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Systolic blood pressure \\< 90 mmHg'}, {'measure': 'Surgery revision', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Surgical re exploration'}, {'measure': 'Vasopressor', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Use of vasopressors as norepinephrine and epinephrine'}, {'measure': 'ICU stay', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Duration of intensive care stay'}, {'measure': 'Hospital stay', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Duration of hospital stay'}, {'measure': 'Mortality', 'timeFrame': 'From icu admission date to icu discharge date an average of 2 weeks', 'description': 'Death of patient'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxygen therapy and Mortality'], 'conditions': ['Oxygen Therapy']}, 'referencesModule': {'references': [{'pmid': '39707209', 'type': 'DERIVED', 'citation': 'Ghazaly HF, Aly AAA, Tammam AS, Hassan MM, Hammad SS, Mahmoud NM, Hemaida TS. Influence of liberal versus conservative oxygen therapies on the hemodynamic parameters of mechanically ventilated patients with sepsis: a randomized clinical trial. BMC Anesthesiol. 2024 Dec 20;24(1):469. doi: 10.1186/s12871-024-02838-6.'}]}, 'descriptionModule': {'briefSummary': 'To assess the benefits and drawbacks of high versus low oxygen therapy on mortality and myocardial function in mechanically ventilated patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults aged 18 years or older admitted to ICU and expected to receive mechanical ventilation beyond next calendar day\n\nExclusion Criteria:\n\n* inclusion in other trial\n* severe acute respiratory distress syndrome at time of admission\n* acute Chronic obstructive airway disease exacerbation\n* pregnancy\n* Carbon monoxide poisoning\n* Guillain Barre syndrome'}, 'identificationModule': {'nctId': 'NCT04824703', 'briefTitle': 'Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Comparative Study Between Liberal and Conservative Oxygen Therapy in Mechanically Ventilated Intensive Care Patients', 'orgStudyIdInfo': {'id': 'Aswu/460/5/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative oxygen therapy', 'description': "* Spo2 alarm limit will be set as follow: - upper limit 94% and lower limit 88%\n* If spo2 \\>94% Unless fio2 is 0.21%, decrease fio2 by 0.10% at intervals no longer than 5 minutes till spo2 = 94%\n* If spo2 within target Decrease fio2 0.05% at intervals no longer than 30 min till fio2 0.21% reached or spo2 = 88 %\n* If spo2 \\< 88 % return to previous spo2 that achieve target spo2.\n* if an arterial blood gas demonstrate that the PaO2 is \\< 60 mmHg FiO2 will increased if clinically appropriate irrespective of the SpO2 reading ( target po2 60-100 mmhg )\n* During intubation, airway suction, tracheostomy, bronchoscopy, transportation outside of the ICU for radiological or other investigations or for procedures or operations, other critical situations such as hemodynamic collapse, patients will receive standard (non-study)treatment.\n* Echocardiography on randomization and at end of the study: we will calculate stroke volume according to Simpson's apical four view", 'interventionNames': ['Drug: Oxygen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Liberal oxygen therapy', 'description': "* Spo2 target \\> 95%\n* No specific measures will be taken to avoid high fio2 or high po2\n* Use of upper alarm limit for spo2 will be prohibited\n* Echocardiography on randomization and at end of the study: we will calculate stroke volume according to Simpson's apical four view", 'interventionNames': ['Drug: Oxygen']}], 'interventions': [{'name': 'Oxygen', 'type': 'DRUG', 'description': '* Decreasing fraction of inspired oxygen and its effect on mortality and myocardial function\n* administered by invasive mechanical ventilation with fraction of inspired oxygen between 0.21 and 1', 'armGroupLabels': ['Conservative oxygen therapy', 'Liberal oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan university hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Ahmed Sayed Mohamed Tammam', 'investigatorAffiliation': 'Aswan University Hospital'}}}}