Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT06816706
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean expiratory airway pressure', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Mean expiratory airway pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Positive end-expiratory pressure', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Positive end-expiratory pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Change of end-expiatory lung volume', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Change of end-expiatory lung volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}], 'secondaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Respiratory rate will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Tidal volume', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Tidal volume will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'End-tidal carbon dioxide', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'End-tidal carbon dioxide will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Pulse oxygen saturation', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Pulse oxygen saturation will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Esophageal pressure-time product', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Esophageal pressure-time product will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Tidal swing of esophageal pressure', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Tidal swing of esophageal pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Respiratory muscle pressure', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Respiratory muscle pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}, {'measure': 'Dynamic transpulmonary pressure', 'timeFrame': 'From enrollment to the end of treatment at 4 hours', 'description': 'Dynamic transpulmonary pressure will be measured during standard and modified high-flow tracheal oxygen versus T-piece.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-flow tracheal oxygen', 'T piece', 'spontaneous breathing trial'], 'conditions': ['Critical Care', 'Oxygen Therapy', 'Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '40962338', 'type': 'DERIVED', 'citation': 'Xu SS, Zhang RZ, An X, Miao MY, Wang YF, Li HL, Zhou JX. Physiological effects of high-flow oxygen via endotracheal tube versus T-piece strategies during spontaneous breathing trials: a study protocol and statistical analysis for a single-centre randomised crossover study. BMJ Open. 2025 Sep 16;15(9):e105360. doi: 10.1136/bmjopen-2025-105360.'}]}, 'descriptionModule': {'briefSummary': 'Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.', 'detailedDescription': 'A spontaneous breathing trial (SBT) is a crucial step in the weaning and extubation process for assessing extubation tolerance. However, the optimal approach for conducting SBTs remains a topic of debate.\n\nHigh-flow nasal oxygen has been shown to provide several physiological benefits, including precise control of the fraction of inspired oxygen, generation of flow-related positive end-expiratory pressure, increased end-expiratory lung volume, improved oxygenation, and enhanced carbon dioxide elimination. High-flow oxygen therapy can also be applied via an artificial airway as high-flow tracheal oxygen. Previous studies have identified this therapy as a potential alternative for SBTs. However, compared to high-flow nasal oxygen, high-flow tracheal oxygen exhibits significantly diminished physiological effects due to the bypassing of the narrow nasopharynx, glottis, and upper airway as well as a more open circuit.\n\nTo address this limitation, the investigators have developed a modified high-flow tracheal oxygen tube with a reduced expiratory end tube diameter. This modification aims to create higher expiratory resistance and airway pressure, thereby simulating the physiological effects of HFNC. This study is a prospective randomized crossover physiological study designed to compare the effects of standard and modified high-flow tracheal oxygen versus T-piece during spontaneous breathing trials. Key physiological parameters will be assessed, including airway pressure, end-expiratory lung volume, vital signs, oxygenation, and respiratory workload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mechanical ventilation for more than 24 hours\n2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials\n\nExclusion Criteria:\n\n1. Age younger than 18 years old\n2. Pregnancy\n3. Hemodynamic instability (mean arterial pressure \\<60 mmHg, heart rate \\>140 or \\<60 bpm)\n4. Respiratory and oxygenation instability (respiratory rate \\> 35bpm or oxygen saturation measured by pulse oximetry \\<90%)\n5. Neuromuscular diseases or phrenic nerve injury\n6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach\n7. Pneumothorax or placement of a chest drainage\n8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)\n9. Anticipating withdrawal of life support'}, 'identificationModule': {'nctId': 'NCT06816706', 'briefTitle': 'Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'IIT2024-157-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified high flow tracheal oxygen-40L/min', 'description': 'Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.', 'interventionNames': ['Procedure: Modified high flow tracheal oxygen-40L/min']}, {'type': 'EXPERIMENTAL', 'label': 'Standard high flow tracheal oxygen-40L/min', 'description': 'Standard high-flow tracheal oxygen with a flow rate of 40L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.', 'interventionNames': ['Procedure: Standard high flow tracheal oxygen-40L/min']}, {'type': 'EXPERIMENTAL', 'label': 'T-piece', 'description': 'T-piece will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.', 'interventionNames': ['Procedure: T-piece']}, {'type': 'EXPERIMENTAL', 'label': 'Modified high-flow tracheal oxygen-60L/min', 'description': 'Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.', 'interventionNames': ['Procedure: Modified high-flow tracheal oxygen-60L/min']}, {'type': 'EXPERIMENTAL', 'label': 'Standard high-flow tracheal oxygen-60L/min', 'description': 'Standard high-flow tracheal oxygen with a flow rate of 60L/min will be performed in mechanically ventilated patients undergoing spontaneous breathing trials.', 'interventionNames': ['Procedure: Standard high-flow tracheal oxygen-60 L/min']}], 'interventions': [{'name': 'Modified high flow tracheal oxygen-40L/min', 'type': 'PROCEDURE', 'description': 'Modified high-flow tracheal oxygen with a flow rate of 40L/min will be performed.', 'armGroupLabels': ['Modified high flow tracheal oxygen-40L/min']}, {'name': 'Standard high flow tracheal oxygen-40L/min', 'type': 'PROCEDURE', 'description': 'Standard high-flow tracheal oxygen with a flow rate of 40 L/min will be performed.', 'armGroupLabels': ['Standard high flow tracheal oxygen-40L/min']}, {'name': 'T-piece', 'type': 'PROCEDURE', 'description': 'T-piece will be performed.', 'armGroupLabels': ['T-piece']}, {'name': 'Modified high-flow tracheal oxygen-60L/min', 'type': 'PROCEDURE', 'description': 'Modified high-flow tracheal oxygen with a flow rate of 60L/min will be performed.', 'armGroupLabels': ['Modified high-flow tracheal oxygen-60L/min']}, {'name': 'Standard high-flow tracheal oxygen-60 L/min', 'type': 'PROCEDURE', 'description': 'Standard high-flow tracheal oxygen with a flow rate of 60 L/min will be performed.', 'armGroupLabels': ['Standard high-flow tracheal oxygen-60L/min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-Xin Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'zhoujx.cn@icloud.com', 'phone': '8610 6392 6666'}, {'name': 'Shan-Shan Xu, MD', 'role': 'CONTACT', 'email': '1004496285@qq.com', 'phone': '8618501219133'}], 'facility': 'Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jian-Xin Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'zhoujx.cn@icloud.com', 'phone': '8610 6392 6666'}, {'name': 'Shan-Shan Xu, MD', 'role': 'CONTACT', 'email': '1004496285@qq.com', 'phone': '8618501219133'}], 'overallOfficials': [{'name': 'Jian-Xin Zhou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jian-Xin Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian-Xin Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}