Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT03430258
Status:
UNKNOWN
Last Update Posted:
2018-02-12
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
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': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.', 'timeFrame': '72 hours', 'description': 'High-flow nasal cannula could reduce the intube rate of patients with blunt thoracic injury,and improve the the lung aeration for patients with thoracic injury'}], 'secondaryOutcomes': [{'measure': 'number of days in ICU', 'timeFrame': '7 days', 'description': 'High-flow nasal cannula could reduce the number of days for the patients treatments in ICU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blunt Thoracic Injury', 'Lung Ultrasound Score']}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.', 'detailedDescription': 'This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (AIS) chest score ≥3) admitted to the ICU\n\nExclusion Criteria:\n\n1. had intubation and used the mechanical ventilation within 2 hours\n2. had the emergency surgerys within 2 hours\n3. patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax\n4. the Glasgow Coma Scale \\<8'}, 'identificationModule': {'nctId': 'NCT03430258', 'briefTitle': 'High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients', 'orgStudyIdInfo': {'id': '19850703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'conventional oxygen therapy', 'description': 'oxygen was delivered by a nasal cannula or nonrebreather mask', 'interventionNames': ['Device: Conventional oxygen therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-flow Nasal Cannula Oxygen Therapy', 'description': 'High-flow Nasal Cannula Oxygen Therapy', 'interventionNames': ['Device: high-flow nasal cannula']}], 'interventions': [{'name': 'high-flow nasal cannula', 'type': 'DEVICE', 'description': 'high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier', 'armGroupLabels': ['High-flow Nasal Cannula Oxygen Therapy']}, {'name': 'Conventional oxygen therapy', 'type': 'DEVICE', 'description': 'Conventional oxygen therapy', 'armGroupLabels': ['conventional oxygen therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}