Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06824220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-13
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High-Flow Tracheal Oxygen on EELI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End-Expiratory Lung Impedance', 'timeFrame': 'From enrollment to the end of treatment at 120 minutes for each patient', 'description': 'End-Expiratory Lung Impedance refers to the electrical impedance of lung tissue measured at the end of expiration, serving as a non-invasive indicator of end-expiratory lung volume (EELV). In the context of high-flow oxygen therapy, changes in EELI reflect variations in lung aeration and recruitment in tracheostomized patients.'}], 'secondaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'From enrollment to the end of treatment at 120 minutes for each patient', 'description': 'Respiratory rate refers to the number of breaths a person takes per minute.'}, {'measure': 'Arterial oxygen saturation', 'timeFrame': 'From enrollment to the end of treatment at 120 minutes for each patient', 'description': 'Arterial oxygen saturation refers to the percentage of hemoglobin in the arterial blood that is bound to oxygen. It is a key indicator of oxygenation efficiency and respiratory function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['end-expiratory lung impedance', 'high-flow tracheal oxygen', 'Tracheostomy'], 'conditions': ['Tracheostomized Patients']}, 'referencesModule': {'references': [{'pmid': '26329355', 'type': 'BACKGROUND', 'citation': 'Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.'}, {'pmid': '33225971', 'type': 'BACKGROUND', 'citation': 'Basile MC, Mauri T, Spinelli E, Dalla Corte F, Montanari G, Marongiu I, Spadaro S, Galazzi A, Grasselli G, Pesenti A. Nasal high flow higher than 60 L/min in patients with acute hypoxemic respiratory failure: a physiological study. Crit Care. 2020 Nov 23;24(1):654. doi: 10.1186/s13054-020-03344-0.'}, {'pmid': '30617626', 'type': 'BACKGROUND', 'citation': 'Stripoli T, Spadaro S, Di Mussi R, Volta CA, Trerotoli P, De Carlo F, Iannuzziello R, Sechi F, Pierucci P, Staffieri F, Bruno F, Camporota L, Grasso S. High-flow oxygen therapy in tracheostomized patients at high risk of weaning failure. Ann Intensive Care. 2019 Jan 7;9(1):4. doi: 10.1186/s13613-019-0482-2.'}, {'pmid': '31591659', 'type': 'BACKGROUND', 'citation': 'Natalini D, Grieco DL, Santantonio MT, Mincione L, Toni F, Anzellotti GM, Eleuteri D, Di Giannatale P, Antonelli M, Maggiore SM. Physiological effects of high-flow oxygen in tracheostomized patients. Ann Intensive Care. 2019 Oct 7;9(1):114. doi: 10.1186/s13613-019-0591-y.'}, {'pmid': '27904928', 'type': 'BACKGROUND', 'citation': 'Corley A, Edwards M, Spooner AJ, Dunster KR, Anstey C, Fraser JF. High-flow oxygen via tracheostomy improves oxygenation in patients weaning from mechanical ventilation: a randomised crossover study. Intensive Care Med. 2017 Mar;43(3):465-467. doi: 10.1007/s00134-016-4634-7. Epub 2016 Nov 30. No abstract available.'}, {'pmid': '27997805', 'type': 'BACKGROUND', 'citation': 'Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.'}, {'pmid': '38432703', 'type': 'BACKGROUND', 'citation': 'Rose L, Messer B. Prolonged Mechanical Ventilation, Weaning, and the Role of Tracheostomy. Crit Care Clin. 2024 Apr;40(2):409-427. doi: 10.1016/j.ccc.2024.01.008. Epub 2024 Feb 2.'}, {'pmid': '28936675', 'type': 'BACKGROUND', 'citation': 'Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22.'}, {'pmid': '24975297', 'type': 'BACKGROUND', 'citation': 'Navalesi P, Frigerio P, Patzlaff A, Haussermann S, Henseke P, Kubitschek M. Prolonged weaning: from the intensive care unit to home. Rev Port Pneumol. 2014 Sep-Oct;20(5):264-72. doi: 10.1016/j.rppneu.2014.04.006. Epub 2014 Jun 26.'}, {'pmid': '36693401', 'type': 'BACKGROUND', 'citation': 'Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.'}, {'pmid': '32962998', 'type': 'BACKGROUND', 'citation': 'Mussa CC, Gomaa D, Rowley DD, Schmidt U, Ginier E, Strickland SL. AARC Clinical Practice Guideline: Management of Adult Patients with Tracheostomy in the Acute Care Setting. Respir Care. 2021 Jan;66(1):156-169. doi: 10.4187/respcare.08206. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this analytical experimental study is to evaluate whether high-flow tracheal oxygen therapy at flow rates above 60 L/min increases end-expiratory lung impedance in tracheostomized patients in the intensive care unit. The main question it aims to answer is whether high-flow tracheal oxygen therapy improves end-expiratory lung impedance in tracheostomized patients.\n\nThis study will be conducted in the Intensive Care Unit of Sanatorio Parque in Rosario, Santa Fe, Argentina, between December 1, 2024, and March 31, 2025. The participant population consists of adult ICU patients (≥18 years old) who are tracheostomized, have undergone at least 10 days of mechanical ventilation, and can tolerate spontaneous breathing for at least 12 hours.\n\nBy analyzing the effects of high-flow tracheal oxygen therapy on lung function, this study aims to generate valuable insights into its physiological impact, potentially influencing clinical management strategies for tracheostomized patients in intensive care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent; ability to tolerate spontaneous breathing for at least 12 hours; arterial oxygen pressure (PaO2) ≥ 60 mm hg or pulse oxygen saturation (SpO2) \\> 90%; corrected metabolic disorders ph ≥ 7.32; hemodynamically stable.\n\nExclusion Criteria:\n\n* neuromuscular or neurodegenerative pathology; contraindication for the use of Electrical Impedance Tomography, RASS \\> +1.'}, 'identificationModule': {'nctId': 'NCT06824220', 'briefTitle': 'Effect of High-Flow Tracheal Oxygen on EELI', 'organization': {'class': 'OTHER', 'fullName': 'Argentinian Intensive Care Society'}, 'officialTitle': 'Effect of High-Flow Tracheal Oxygen on End-Expiratory Lung Impedance in Tracheostomized Patients', 'orgStudyIdInfo': {'id': '#09122024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients', 'description': 'Implementation of High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients for 20 minutes and End-Expiratory Lung Impedance evaluation', 'interventionNames': ['Device: High-Flow Tracheal Oxygen']}], 'interventions': [{'name': 'High-Flow Tracheal Oxygen', 'type': 'DEVICE', 'description': 'High-Flow Tracheal Oxygen is the use of high oxygen flows in tracheostomized patients. Unlike conventional oxygen therapy which is performed through siliconized nasal prongs, this is done through a connector directly on the tracheostomy tube.', 'armGroupLabels': ['High-Flow Tracheal Oxygen 70 and 80 L/m in Tracheostomized Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S2000QGB', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio Parque', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Argentinian Intensive Care Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital Británico de Buenos Aires', 'investigatorFullName': 'Gustavo Plotnikow', 'investigatorAffiliation': 'Argentinian Intensive Care Society'}}}}