Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-06 @ 5:51 AM
Study NCT ID:
NCT06344234
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV', 'timeFrame': '24 hours', 'description': 'To investigate the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV'}], 'primaryOutcomes': [{'measure': 'Statistic metric of association between ΔPocc and ΔPes', 'timeFrame': '24 hours', 'description': 'to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure'}], 'secondaryOutcomes': [{'measure': 'Statistic metric of association between P0.1, ΔP, PMI and ΔPes', 'timeFrame': '24 hours'}, {'measure': 'Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio', 'timeFrame': '24 hours'}, {'measure': 'Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume', 'timeFrame': '24 hours'}, {'measure': 'Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%', 'timeFrame': '24 hours'}, {'measure': 'Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%', 'timeFrame': '24 hours'}, {'measure': 'Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noninvasive ventilation', 'respiration, artificial', 'Ventilators, Mechanical', 'Positive End-Expiratory Pressure'], 'conditions': ['Respiratory Disease', 'Artificial Respiration']}, 'referencesModule': {'references': [{'pmid': '33764378', 'type': 'BACKGROUND', 'citation': "Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682."}, {'pmid': '37326646', 'type': 'BACKGROUND', 'citation': "Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16."}, {'pmid': '27753501', 'type': 'BACKGROUND', 'citation': 'Bellani G, Laffey JG, Pham T, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome. Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. doi: 10.1164/rccm.201606-1306OC.'}, {'pmid': '33653913', 'type': 'BACKGROUND', 'citation': "Menga LS, Cese LD, Bongiovanni F, Lombardi G, Michi T, Luciani F, Cicetti M, Timpano J, Ferrante MC, Cesarano M, Anzellotti GM, Rosa T, Natalini D, Tanzarella ES, Cutuli SL, Pintaudi G, De Pascale G, Dell'Anna AM, Bello G, Pennisi MA, Maggiore SM, Maviglia R, Grieco DL, Antonelli M. High Failure Rate of Noninvasive Oxygenation Strategies in Critically Ill Subjects With Acute Hypoxemic Respiratory Failure Due to COVID-19. Respir Care. 2021 May;66(5):705-714. doi: 10.4187/respcare.08622. Epub 2021 Mar 2."}, {'pmid': '30871304', 'type': 'BACKGROUND', 'citation': 'Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.'}, {'pmid': '35246748', 'type': 'BACKGROUND', 'citation': 'Chi Y, Zhao Z, Frerichs I, Long Y, He H. Prevalence and prognosis of respiratory pendelluft phenomenon in mechanically ventilated ICU patients with acute respiratory failure: a retrospective cohort study. Ann Intensive Care. 2022 Mar 5;12(1):22. doi: 10.1186/s13613-022-00995-w.'}, {'pmid': '33140181', 'type': 'BACKGROUND', 'citation': 'Goligher EC, Jonkman AH, Dianti J, Vaporidi K, Beitler JR, Patel BK, Yoshida T, Jaber S, Dres M, Mauri T, Bellani G, Demoule A, Brochard L, Heunks L. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort. Intensive Care Med. 2020 Dec;46(12):2314-2326. doi: 10.1007/s00134-020-06288-9. Epub 2020 Nov 2.'}, {'pmid': '32016537', 'type': 'BACKGROUND', 'citation': 'Spinelli E, Mauri T, Beitler JR, Pesenti A, Brodie D. Respiratory drive in the acute respiratory distress syndrome: pathophysiology, monitoring, and therapeutic interventions. Intensive Care Med. 2020 Apr;46(4):606-618. doi: 10.1007/s00134-020-05942-6. Epub 2020 Feb 3.'}, {'pmid': '32325004', 'type': 'BACKGROUND', 'citation': "Tonelli R, Fantini R, Tabbi L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respiratory Failure. A Pilot Study. Am J Respir Crit Care Med. 2020 Aug 15;202(4):558-567. doi: 10.1164/rccm.201912-2512OC."}, {'pmid': '36378814', 'type': 'BACKGROUND', 'citation': "Menga LS, Delle Cese L, Rosa T, Cesarano M, Scarascia R, Michi T, Biasucci DG, Ruggiero E, Dell'Anna AM, Cutuli SL, Tanzarella ES, Pintaudi G, De Pascale G, Sandroni C, Maggiore SM, Grieco DL, Antonelli M. Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial. Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. doi: 10.1164/rccm.202204-0629OC."}, {'pmid': '31815775', 'type': 'BACKGROUND', 'citation': 'Yoshida T, Grieco DL, Brochard L, Fujino Y. Patient self-inflicted lung injury and positive end-expiratory pressure for safe spontaneous breathing. Curr Opin Crit Care. 2020 Feb;26(1):59-65. doi: 10.1097/MCC.0000000000000691.'}, {'pmid': '32204729', 'type': 'BACKGROUND', 'citation': 'Bertoni M, Spadaro S, Goligher EC. Monitoring Patient Respiratory Effort During Mechanical Ventilation: Lung and Diaphragm-Protective Ventilation. Crit Care. 2020 Mar 24;24(1):106. doi: 10.1186/s13054-020-2777-y.'}, {'pmid': '31694692', 'type': 'BACKGROUND', 'citation': 'Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.'}, {'pmid': '30460251', 'type': 'BACKGROUND', 'citation': 'Mojoli F, Torriglia F, Orlando A, Bianchi I, Arisi E, Pozzi M. Technical aspects of bedside respiratory monitoring of transpulmonary pressure. Ann Transl Med. 2018 Oct;6(19):377. doi: 10.21037/atm.2018.08.37.'}, {'pmid': '32623476', 'type': 'BACKGROUND', 'citation': 'Dianti J, Bertoni M, Goligher EC. Monitoring patient-ventilator interaction by an end-expiratory occlusion maneuver. Intensive Care Med. 2020 Dec;46(12):2338-2341. doi: 10.1007/s00134-020-06167-3. Epub 2020 Jul 4. No abstract available.'}, {'pmid': '1144940', 'type': 'BACKGROUND', 'citation': 'Whitelaw WA, Derenne JP, Milic-Emili J. Occlusion pressure as a measure of respiratory center output in conscious man. Respir Physiol. 1975 Mar;23(2):181-99. doi: 10.1016/0034-5687(75)90059-6.'}, {'pmid': '29350241', 'type': 'BACKGROUND', 'citation': 'Telias I, Damiani F, Brochard L. The airway occlusion pressure (P0.1) to monitor respiratory drive during mechanical ventilation: increasing awareness of a not-so-new problem. Intensive Care Med. 2018 Sep;44(9):1532-1535. doi: 10.1007/s00134-018-5045-8. Epub 2018 Jan 19. No abstract available.'}, {'pmid': '30006893', 'type': 'BACKGROUND', 'citation': 'Bellani G, Grassi A, Sosio S, Foti G. Plateau and driving pressure in the presence of spontaneous breathing. Intensive Care Med. 2019 Jan;45(1):97-98. doi: 10.1007/s00134-018-5311-9. Epub 2018 Jul 13. No abstract available.'}, {'pmid': '9351624', 'type': 'BACKGROUND', 'citation': 'Foti G, Cereda M, Banfi G, Pelosi P, Fumagalli R, Pesenti A. End-inspiratory airway occlusion: a method to assess the pressure developed by inspiratory muscles in patients with acute lung injury undergoing pressure support. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1210-6. doi: 10.1164/ajrccm.156.4.96-02031.'}, {'pmid': '23344830', 'type': 'BACKGROUND', 'citation': 'Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.'}, {'pmid': '28360224', 'type': 'BACKGROUND', 'citation': 'Dube BP, Dres M, Mayaux J, Demiri S, Similowski T, Demoule A. Ultrasound evaluation of diaphragm function in mechanically ventilated patients: comparison to phrenic stimulation and prognostic implications. Thorax. 2017 Sep;72(9):811-818. doi: 10.1136/thoraxjnl-2016-209459. Epub 2017 Mar 30.'}, {'pmid': '22476448', 'type': 'BACKGROUND', 'citation': 'Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.'}, {'pmid': '7149443', 'type': 'BACKGROUND', 'citation': 'Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. doi: 10.1164/arrd.1982.126.5.788.'}, {'pmid': '26868503', 'type': 'BACKGROUND', 'citation': 'Chiumello D, Consonni D, Coppola S, Froio S, Crimella F, Colombo A. The occlusion tests and end-expiratory esophageal pressure: measurements and comparison in controlled and assisted ventilation. Ann Intensive Care. 2016 Dec;6(1):13. doi: 10.1186/s13613-016-0112-1. Epub 2016 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.\n\nThe main questions this trial aims to answer are:\n\n\\- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.\n\nSecondary outcomes will include:\n\n* Statistic metric of association between P0.1, ΔP, PMI and ΔPes\n* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio\n* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume\n* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%\n* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%\n* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.\n\nParticipants will undergo the following tasks and treatments:\n\n* Complete written informed consent before enrollment.\n* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.\n* Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test)\n* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.\n* Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively.\n* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).\n* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All hypoxemic patients with a PaO2/FiO2 ratio equal or lower than 300, receiving post-extubation noninvasive ventilation via an nose-to-mouth or a full-face mask, will be screened for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years.\n* Non-pregnant and non-lactating.\n* Monitored through esophageal pressure for clinical decision before extubation.\n* Able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with severe facial trauma or deformity that precludes the placement of a facemask or esophageal catheter.\n* Patients with neuromuscular disorders that may impair inspiratory drive and effort.\n* Patients with acute exacerbation of COPD\n* Patients with esophageal or tracheal abnormalities that impede esophageal manometry.\n* Patients with a known hypersensitivity or allergy to any of the materials used in the study.\n* Excessive air leak (difference between inspiratory and expiratory tidal volume major or equal to 10%)'}, 'identificationModule': {'nctId': 'NCT06344234', 'acronym': 'INSPIRE', 'briefTitle': 'Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari'}, 'officialTitle': 'Noninvasive Assessment of Inspiratory Effort and Tidal Distension During Noninvasive Ventilation. The INSPIRE Study.', 'orgStudyIdInfo': {'id': '0049191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort (n=60)', 'description': 'All hypoxemic patients with a PaO2/FiO2 ratio equal or lower than 300, receiving post-extubation noninvasive ventilation.\n\nParticipants will undergo the following tasks and treatments:\n\n* Complete written informed consent before enrollment.\n* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.\n* Monitoring of esophageal pressure\n* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.\n* Sudden end-inspiratory and end-expiratory occlusion maneuvers.\n* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).\n* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions.', 'interventionNames': ['Diagnostic Test: End-inspiratory Maneuvers']}], 'interventions': [{'name': 'End-inspiratory Maneuvers', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['End-Expiratory Occlusion Maneuvers', 'Esophageal pressure monitoring', 'Diaphragmatic ultrasounds'], 'description': "Airway pressure, flow, and esophageal pressure will be continuously recorded in all patients using a dedicated pneumotachograph and pressure transducer: all signals will be acquired and stored. Once a stable ventilation pattern is observed NIV will be administered by setting ventilator in invasive-pressure support ventilation. PEEP and PS-level will by kept constant while expiratory trigger will be adjusted to optimize patient-ventilatory synchrony. Immediately after, sudden end-inspiratory and end-expiratory occlusion maneuvers will be performed to measure plateau pressure and end-expiratory airway occlusion pressure (ΔPocc), respectively. Invasive PSV will be used only to perform the occlusion maneuvers, subsequently, PSV will be delivered in non-invasive PSV mode. Patient's blood-gas parameters and vital signs will be collected, including discomfort assessment. During the occlusion maneuvers, diaphragm ultrasound will be performed, and images will be recorded.", 'armGroupLabels': ['Cohort (n=60)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Grasso, MD, Professor', 'role': 'CONTACT', 'email': 'salvatore.grasso@uniba.it'}, {'name': 'Francesco Murgolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Domenico Luca Grieco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda ospedaliero-universitaria consorziale policlinico di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Francesco Murgolo, MD', 'role': 'CONTACT', 'email': 'salvatore.grasso@uniba.it', 'phone': '++393923688291'}], 'overallOfficials': [{'name': 'Salvatore Grasso, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Salvatore Grasso', 'investigatorAffiliation': 'University of Bari'}}}}