Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT03229460
Status:
UNKNOWN
Last Update Posted:
2018-12-05
First Post:
2017-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-07-23', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients in each group who require endotracheal intubation with mechanical ventilation', 'timeFrame': '28days', 'description': 'To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'mechanical ventilation-free to day 28', 'timeFrame': '28 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure With Hypercapnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.', 'detailedDescription': "Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypoxemic and no hypercapnic acute respiratory failure :\n* severe dyspnea at rest with a respiratory rate \\>25 breaths/min\n* PaO2/FiO2 \\<300\n* PaCO2 \\<45 mmHg,\n\nExclusion Criteria:\n\n* age \\<18 years\n* NPPV contraindications\n* past history of respiratory chronic disease (COPD, cystic fibrosis…)\n* cardiac pulmonary edema\n* Pre-defined intubation\n* other than respiratory organ failure : systolic pressure \\<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)\n* profound aplasia (white cells count \\<1000/mm 3)'}, 'identificationModule': {'nctId': 'NCT03229460', 'briefTitle': 'High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure', 'orgStudyIdInfo': {'id': 'XH-17-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard low flow therapy', 'description': 'In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.', 'interventionNames': ['Other: standard low flow therapy']}, {'type': 'EXPERIMENTAL', 'label': 'high flow nasal oxygen therapy', 'description': 'In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.', 'interventionNames': ['Device: high flow nasal oxygen therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Noninvasive ventilation', 'description': 'In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.', 'interventionNames': ['Device: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation']}], 'interventions': [{'name': 'standard low flow therapy', 'type': 'OTHER', 'description': 'In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.', 'armGroupLabels': ['standard low flow therapy']}, {'name': 'high flow nasal oxygen therapy', 'type': 'DEVICE', 'description': 'The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \\>92%.', 'armGroupLabels': ['high flow nasal oxygen therapy']}, {'name': 'association of high flow nasal oxygen therapy and non invasive positive pressure ventilation', 'type': 'DEVICE', 'description': 'The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \\>92% with the minimal FiO2.', 'armGroupLabels': ['Noninvasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangyu Chen, PhD', 'role': 'CONTACT', 'email': 'xinhuacru@163.com', 'phone': '+86-02125076143'}], 'facility': 'Ethics Committee of Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'bin he', 'role': 'CONTACT', 'email': 'hebinicu@139.com', 'phone': '021-25077828'}, {'name': 'dongjuan tang', 'role': 'CONTACT', 'email': '317582862@qq.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D./Ph.D.', 'investigatorFullName': 'Bin He', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}