Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-03 @ 4:45 AM
Study NCT ID:
NCT06689020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Expiratory Pressure (PEP) and Continuous High-frequency Oscillation (CHFO) on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C075403', 'term': 'cholesterylphosphorylethylpyridinium'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess changes in systemic oxygenation', 'timeFrame': 'Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment', 'description': 'Arterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)'}, {'measure': 'Changes in lung recruitment using EIT', 'timeFrame': 'Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment', 'description': 'Absolute reduction in the percentage (%) of lung volume collapse assessed with the electrical impedance tomography (EIT)'}], 'secondaryOutcomes': [{'measure': 'Mean arterial pressure, mmHg', 'timeFrame': 'Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment', 'description': 'Heart rate as measured by continuous pressure monitoring'}, {'measure': 'Heart rate min-1', 'timeFrame': 'Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment', 'description': 'Heart rate as measured by continuous electrocardiogram monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recruitment', 'Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '37097986', 'type': 'RESULT', 'citation': 'Jonkman AH, Alcala GC, Pavlovsky B, Roca O, Spadaro S, Scaramuzzo G, Chen L, Dianti J, Sousa MLA, Sklar MC, Piraino T, Ge H, Chen GQ, Zhou JX, Li J, Goligher EC, Costa E, Mancebo J, Mauri T, Amato M, Brochard LJ; Pleural Pressure Working Group (PLUG). Lung Recruitment Assessed by Electrical Impedance Tomography (RECRUIT): A Multicenter Study of COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2023 Jul 1;208(1):25-38. doi: 10.1164/rccm.202212-2300OC.'}, {'pmid': '31410738', 'type': 'RESULT', 'citation': 'Longhini F, Maugeri J, Andreoni C, Ronco C, Bruni A, Garofalo E, Pelaia C, Cavicchi C, Pintaudi S, Navalesi P. Electrical impedance tomography during spontaneous breathing trials and after extubation in critically ill patients at high risk for extubation failure: a multicenter observational study. Ann Intensive Care. 2019 Aug 13;9(1):88. doi: 10.1186/s13613-019-0565-0.'}, {'pmid': '34063429', 'type': 'RESULT', 'citation': 'Battaglini D, Caiffa S, Gasti G, Ciaravolo E, Robba C, Herrmann J, Gerard SE, Bassetti M, Pelosi P, Ball L, On Behalf Of The Gecovid Group. An Experimental Pre-Post Study on the Efficacy of Respiratory Physiotherapy in Severe Critically III COVID-19 Patients. J Clin Med. 2021 May 15;10(10):2139. doi: 10.3390/jcm10102139.'}, {'pmid': '29485340', 'type': 'RESULT', 'citation': 'Reychler G, Uribe Rodriguez V, Hickmann CE, Tombal B, Laterre PF, Feyaerts A, Roeseler J. Incentive spirometry and positive expiratory pressure improve ventilation and recruitment in postoperative recovery: A randomized crossover study. Physiother Theory Pract. 2019 Mar;35(3):199-205. doi: 10.1080/09593985.2018.1443185. Epub 2018 Feb 27.'}, {'pmid': '31113857', 'type': 'RESULT', 'citation': 'Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.'}]}, 'descriptionModule': {'briefSummary': 'This single-center observational study aims to assess the effects of continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy on lung recruitment using electrical impedance tomography (EIT) in spontaneously breathing patients admitted to the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are spontaneously breathing and admitted to the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who require pulmonary expansion and airway clearing as per clinical indication\n* Patients who provide valid informed consent according to local regulations\n* PaO2/FiO2 \\< 200 mmHg at inclusion\n* Patient on the Airway Care Score (ACS) \\< 7\n\nExclusion Criteria:\n\n* Refuse to participate\n* Age \\< 18 years\n* Hemodynamic instability, defined as systolic arterial pressure \\< 90 mmHg or mean pressure \\< 60 mmHg\n* Contraindication to using an EIT (i.e., pacemaker or defibrillator)\n* Inability to properly position the EIT device for anatomical reasons'}, 'identificationModule': {'nctId': 'NCT06689020', 'acronym': 'PEP-RECRUIT', 'briefTitle': 'Positive Expiratory Pressure (PEP) and Continuous High-frequency Oscillation (CHFO) on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Genova'}, 'officialTitle': 'Effect of Continuous High-frequency Oscillation (CHFO) and Continuous Positive Expiratory Pressure (CPEP) Therapy on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study', 'orgStudyIdInfo': {'id': 'PEP-RECRUIT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy', 'type': 'PROCEDURE', 'description': 'During application of CPEP and CHFO, EIT is monitored.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'contacts': [{'name': 'Denise Battaglini, MD, PhD', 'role': 'CONTACT', 'email': 'battaglini.denise@gmail.com', 'phone': '+39-0105554970'}, {'name': 'Lorenzo Ball, MD, PhD', 'role': 'CONTACT', 'email': 'lorenzo.ball@unige.it', 'phone': '+39-0105554970'}], 'facility': 'UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'centralContacts': [{'name': 'Denise Battaglini, MD, PhD', 'role': 'CONTACT', 'email': 'battaglini.denise@gmail.com', 'phone': '+39-0105554970'}, {'name': 'Lorenzo Ball, MD, PhD', 'role': 'CONTACT', 'email': 'lorenzo.ball@unige.it', 'phone': '+39-0105554970'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Genova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Denise Battaglini', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Lorenzo Ball', 'investigatorAffiliation': 'University of Genova'}}}}