Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT03534960
Status:
UNKNOWN
Last Update Posted:
2018-05-29
First Post:
2017-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
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'}]}}, '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': '2018-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2018-05-13', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients in each group who require endotracheal intubation w', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'mechanical ventilation-free to day 28', 'timeFrame': '28 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': "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 pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.", '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 pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ranges from 1 to 18 years\n2. Hypercapnic respiratory failure:\n\n PaO2\\<60mmHg and PaCO2 \\>50 mmHg\n3. Candidate for non-invasive respiratory support as a result of:\n\n 1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support\n 2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support\n\nExclusion Criteria:\n\n1. Participation in a concurrent study that prohibits the use of HHFNC\n2. Active air leak syndrome\n3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,\n4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia\n5. PaCO2\\<50mmHg'}, 'identificationModule': {'nctId': 'NCT03534960', 'briefTitle': 'High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage', 'orgStudyIdInfo': {'id': 'XH-17-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High Flow Nasal Oxygen Therapy', 'description': 'Patients are randomized to the high flow nasal oxygen therapy group', 'interventionNames': ['Device: High Flow Nasal Oxygen Therapy']}, {'type': 'OTHER', 'label': 'Nasal CPAP', 'description': 'Patients are randomized to the nasal continuous positive airway pressure treatment group', 'interventionNames': ['Device: Nasal CPAP']}], 'interventions': [{'name': 'High Flow Nasal Oxygen Therapy', 'type': 'DEVICE', 'description': 'Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas', 'armGroupLabels': ['High Flow Nasal Oxygen Therapy']}, {'name': 'Nasal CPAP', 'type': 'DEVICE', 'description': 'Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O', 'armGroupLabels': ['Nasal CPAP']}]}, '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': 'xingyu tong', 'role': 'CONTACT', 'email': '2433928723@qq.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bin He', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}