Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT03527992
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2018-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length in days of hospital stay', 'timeFrame': '1 month', 'description': 'measure of total days of hospitalization and intensive care'}], 'secondaryOutcomes': [{'measure': 'Duration of oxygen therapy', 'timeFrame': '1 month', 'description': 'Oxygen therapy time evaluation during hospitalization of patient'}, {'measure': 'Time spent outside of the target saturation', 'timeFrame': '1 month', 'description': 'Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,'}, {'measure': 'the cost on the medical-economic level', 'timeFrame': '1 month', 'description': 'investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"'}, {'measure': 'rate of medical complication', 'timeFrame': '1 month', 'description': 'Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"'}, {'measure': "quality questionnaire of patient's life during hospitalization", 'timeFrame': '1 month', 'description': 'Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized Therapeutic trial', 'Hypoxemic pneumonia', 'Automated oxygen therapy', 'Length of stay', 'medico-economic cost'], 'conditions': ['Pneumonia', 'Pneumonia, Ventilator-Associated', 'Length of Stay']}, 'descriptionModule': {'briefSummary': "Hypoxemic pneumonia is a major cause of hospitalization in Pulmonology. The patient's dependency on oxygen prevents early discharge from the hospital. An automated oxygen therapy is a system that allows administration of oxygen with a flow that is automatically adjusted to the patient's saturation, which is continuously monitored. This system has proven to be particularly effective with chronic obstructive pulmonary disease (COPD) patients, by decreasing the time spent in hypoxia and hyperoxia, and by accelerating the weaning of oxygen. Our hypothesis is that automated oxygen therapy leads to a diminution on the length of hospital stay.", 'detailedDescription': "Prolonged hospitalization has many consequences, including loss of autonomy and nosocomial infection. Moreover, these complications themselves lead to an extension of the length of stay. This has an impact on the cost of care: several studies have shown that hospitalization is the most costly factor in the management of pneumonia, and that even a small amount of hospital stay, led to significant financial savings. Automated oxygen therapy is a device that automatically adjusts with the saturation the amount of oxygen administered. Investigator hypothesis is that automated oxygen therapy could shorten the length of stay of patients hospitalized for hypoxemic pneumonia. One group of patients will receive the automated oxygen therapy and the other group will receive the standard Oxygen therapy. The investigator will compare in each group the average length of stay, the duration of oxygen therapy, the time spent outside of the target saturation, the cost on the medical-economic level and the patient's experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Patient living at home or in an institution\n* Patient hospitalized for less than 48 hours\n* Pneumonia defined (according to the 2006 French-speaking infectious pneumology society (SPILF) criteria) by:\n\n * respiratory functional symptoms (cough, sputum, dyspnea, chest pain) and\n * Hyperthermia \\>38,5°C or hypothermia \\<36°C and\n * Radiological Signs of Pneumonia\n* Hypoxia : SpO2 \\< 94% in ambient air and/or PaO2\\< 60 mmHg in ambient air\n\nExclusion Criteria:\n\n* Pneumonia acquired at the hospital.\n* Patient hospitalized in another department more than 48 hours before admission\n* Chronic respiratory failure\n* Active neoplasia\n* Patients undergoing oxygen therapy and / or long-term NIV\n* Associated cardiac decompensation (clinical signs and / or NTproBNP\\> 1800ng / mL) (3\n* Initial Need for high flow oxygen therapy or ventilatory support (NIV, VI)\n* Difficulties expected from home support.'}, 'identificationModule': {'nctId': 'NCT03527992', 'acronym': 'OPPAÎ', 'briefTitle': 'Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia', 'orgStudyIdInfo': {'id': 'RC31/17/0404'}, 'secondaryIdInfos': [{'id': '2017-A03642-51', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Automated oxygen therapy', 'description': "An automated oxygen therapy is a system that allows administration of oxygen with a flow that is automatically adjusted to the patient's saturation, which is continuously monitored. Patients will receive O2 automated intervention.", 'interventionNames': ['Device: O2 automated']}, {'type': 'OTHER', 'label': 'Standard Oxygen therapy', 'description': 'Patients will receive O2 standard therapy', 'interventionNames': ['Device: O2 standard']}], 'interventions': [{'name': 'O2 automated', 'type': 'DEVICE', 'description': 'In the "O2 automated" group, patients benefit from oxygen therapy via the "FreeO2" device. The O2 saturation target is set by the clinician on the device. Saturation is continuously sensed by an oximeter and the oxygen flow is automatically adjusted. The clinician has access to instantaneous values and trends of O2 and SpO2 flow rates.', 'armGroupLabels': ['Automated oxygen therapy']}, {'name': 'O2 standard', 'type': 'DEVICE', 'description': 'In the "O2 standard" group, patients benefit from oxygen therapy with nasal goggles or a high concentration mask. Saturation is continuously captured by an oximeter. The flow rate of oxygen, evaluated in L/min, is adapted according to local protocols (every 8 hours in conventional hospital services, continuous in intensive care', 'armGroupLabels': ['Standard Oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31049', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elise Noel-Savina, MD', 'role': 'CONTACT', 'email': 'noel-savina.e@chu-toulouse.fr', 'phone': '5 67 77 16 90', 'phoneExt': '33'}, {'name': 'Elise Noel-Savina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sandrine Pontier-Marchandise, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alain Didier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Elise Noel-Savina, MD', 'role': 'CONTACT', 'email': 'noel-savina.e@chu-toulouse.fr', 'phone': '5 67 77 16 90', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Elise Noel-Savina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}