Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05759832
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2023-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy
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': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need to increase ventilatory support', 'timeFrame': 'Within 24 hours after bronchoscopy', 'description': 'The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria:\n\n1. Escalation to invasive mechanical ventilation (IMV);\n2. Escalation to non-invasive ventilation (NIV);\n3. Escalation to HFNC oxygen therapy;\n4. An increase in support parameters without changing the level of respiratory support: For NIV patients: a \\>20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a \\>20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a \\>50% increase in oxygen flow rate.'}], 'secondaryOutcomes': [{'measure': 'A hierarchy of escalated respiratory support forms based on clinical severity', 'timeFrame': 'Within 24 hours after bronchoscopy', 'description': 'A hierarchical composite outcome, assessed in a fixed sequence: escalation to IMV, escalation to NIV, escalation to HFNO therapy, and an increase in support parameters without changing the level of respiratory support.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Hypoxemic Respiratory Failure', 'High-flow Nasal Cannula Oxygen']}, 'referencesModule': {'references': [{'pmid': '27016353', 'type': 'BACKGROUND', 'citation': 'Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.'}, {'pmid': '25003980', 'type': 'BACKGROUND', 'citation': 'Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.'}, {'pmid': '25980431', 'type': 'BACKGROUND', 'citation': 'Del Sorbo L, Ferguson ND. High-Flow Nasal Cannulae or Noninvasive Ventilation for Management of Postoperative Respiratory Failure. JAMA. 2015 Jun 16;313(23):2325-6. doi: 10.1001/jama.2015.5304. No abstract available.'}, {'pmid': '23128844', 'type': 'BACKGROUND', 'citation': 'Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.'}, {'pmid': '421510', 'type': 'BACKGROUND', 'citation': 'Miller EJ. Hypoxemia during fiberoptic bronchoscopy. Chest. 1979 Jan;75(1):103. doi: 10.1378/chest.75.1.103b. No abstract available.'}, {'pmid': '1862254', 'type': 'BACKGROUND', 'citation': 'Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.'}, {'pmid': '16924893', 'type': 'BACKGROUND', 'citation': 'Fang WF, Chen YC, Chung YH, Woon WT, Tseng CC, Chang HW, Lin MC. Predictors of oxygen desaturation in patients undergoing diagnostic bronchoscopy. Chang Gung Med J. 2006 May-Jun;29(3):306-12.'}, {'pmid': '33927023', 'type': 'BACKGROUND', 'citation': 'Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.'}, {'pmid': '29171661', 'type': 'BACKGROUND', 'citation': 'Douglas N, Ng I, Nazeem F, Lee K, Mezzavia P, Krieser R, Steinfort D, Irving L, Segal R. A randomised controlled trial comparing high-flow nasal oxygen with standard management for conscious sedation during bronchoscopy. Anaesthesia. 2018 Feb;73(2):169-176. doi: 10.1111/anae.14156. Epub 2017 Nov 24.'}, {'pmid': '33105418', 'type': 'BACKGROUND', 'citation': 'Irfan M, Ahmed M, Breen D. Assessment of High Flow Nasal Cannula Oxygenation in Endobronchial Ultrasound Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2021 Apr 1;28(2):130-137. doi: 10.1097/LBR.0000000000000719.'}, {'pmid': '32265363', 'type': 'BACKGROUND', 'citation': "Ben-Menachem E, McKenzie J, O'Sullivan C, Havryk AP. High-flow Nasal Oxygen Versus Standard Oxygen During Flexible Bronchoscopy in Lung Transplant Patients: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Oct;27(4):259-265. doi: 10.1097/LBR.0000000000000670."}, {'pmid': '25529351', 'type': 'BACKGROUND', 'citation': 'Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.'}, {'pmid': '33262584', 'type': 'BACKGROUND', 'citation': 'Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.'}, {'pmid': '34775948', 'type': 'BACKGROUND', 'citation': 'Wang R, Li HC, Li XY, Tang X, Chu HW, Yuan X, Tong ZH, Sun B. Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. BMC Pulm Med. 2021 Nov 14;21(1):367. doi: 10.1186/s12890-021-01744-8.'}]}, 'descriptionModule': {'briefSummary': "Acute respiratory failure (AFR) is a serious condition that requires prompt and appropriate intervention to prevent further deterioration and improve outcomes. Bronchoscopy is a commonly used diagnostic and therapeutic procedure in patients with respiratory failure. However, traditional low-flow oxygen supplementation during bronchoscopy may not provide adequate oxygenation and ventilation, leading to complications and worsening of the patient's condition.\n\nHigh-flow nasal cannula therapy has improved oxygenation and ventilation in critically ill patients, making it a promising alternative to traditional oxygen supplementation during bronchoscopy. The bronchoscope is passed through the nose during all procedures in our center. HFNC oxygen therapy is applied to both nostrils. The bronchoscope occupies one of the nares receiving oxygen therapy during bronchoscopy. As a result, the application of HFNC needs to be optimized. Therefore, the investigators designed a modified HFNC with a single cannula. However, limited data exist on the safety and efficacy of modified HFNC therapy in patients with respiratory failure undergoing bronchoscopy.\n\nTherefore, the aim of this study is to evaluate the impact of modified HFNC therapy on the outcomes of undergoing bronchoscopy in patients with ARF. The findings of this study will contribute to understanding the role of modified HFNC therapy in managing ARF and inform clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Respiratory failure defined as a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) \\<300 mm Hg;\n3. Clinical indication for FB to diagnose or treat pulmonary disease.\n\nExclusion Criteria:\n\n1. Pre-existing endotracheal intubation or tracheostomy;\n2. Required immediate endotracheal intubation;\n3. PaO2/FiO2 \\<150 mm Hg;\n4. Platelet count \\<60 × 109/L;\n5. History of myocardial infarction within the past 6 weeks;\n6. Nasopharyngeal obstruction or blockage;\n7. Presence of chest skin lesions contraindicating the application of electrical impedance tomography (EIT);\n8. Intolerance to HFNC oxygen therapy.'}, 'identificationModule': {'nctId': 'NCT05759832', 'briefTitle': 'Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy', 'orgStudyIdInfo': {'id': '2023-KE-17'}, 'secondaryIdInfos': [{'id': 'PX2023010', 'type': 'OTHER_GRANT', 'domain': 'Beijing Hospitals Authority'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified HFNC oxygen therapy group', 'interventionNames': ['Device: Modified HFNC oxygen therapy']}, {'type': 'OTHER', 'label': 'Standard oxygen therapy', 'description': 'Non-rebreathing reservoir mask', 'interventionNames': ['Device: Non-rebreathing reservoir mask']}], 'interventions': [{'name': 'Modified HFNC oxygen therapy', 'type': 'DEVICE', 'description': 'In the modified HFNC group, high-flow devices (AIRVOTM 2; Fisher \\& Paykel Healthcare, Auckland, New Zealand) were utilized for respiratory support. The nasal cannula used was a modified single nasal cannula.', 'armGroupLabels': ['Modified HFNC oxygen therapy group']}, {'name': 'Non-rebreathing reservoir mask', 'type': 'DEVICE', 'description': 'In the non-rebreathing reservoir mask group, oxygen was delivered via a non-rebreathing reservoir mask during bronchoscopy. The oxygen flow was set to achieve a saturation of pulse oxygen \\> 90%.', 'armGroupLabels': ['Standard oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '810000', 'city': 'Xining', 'state': 'Qinghai', 'country': 'China', 'facility': 'Affiliated Hospital of Qinghai University', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}], 'overallOfficials': [{'name': 'Rui Wang, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Hospital of Qinghai University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctors', 'investigatorFullName': 'Rui Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}