Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02574169
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2015-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2015-09-19', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of oxygen tissue partial pressure (PtiO2) values', 'timeFrame': '60 minutes', 'description': 'The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP'}], 'secondaryOutcomes': [{'measure': 'Comparison of systemic hemodynamic parameters', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.'}, {'measure': 'Comparison of Intracranial hemodynamic parameters', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of Intracranial hemodynamic parameters: ICP (Intracranial pressure) , cerebral perfusion pressure and Transcranial Doppler (pulsatility index, mean, systolic and diastolic velocities)'}, {'measure': 'Comparison of blood oxygen level', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)'}, {'measure': 'Comparison of partial pressure of carbon dioxide', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),'}, {'measure': 'Comparison of arterial blood gases', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),'}, {'measure': 'Comparison of end-tidal CO2', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of end-tidal CO2'}, {'measure': 'Comparison of Respiratory parameters', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.'}, {'measure': 'Comparison of PtiO2', 'timeFrame': '60 minutes', 'description': 'Comparison between the two ARM of PtiO2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alveolar Recruitment Maneuvers (ARM)', 'Continuous Positive Airway Pressure (CPAP)', 'Extended Sigh (eSigh)'], 'conditions': ['Cerebral Injuries', 'Acute Respiratory Distress Syndrome (ARDS)']}, 'referencesModule': {'references': [{'pmid': '18416847', 'type': 'BACKGROUND', 'citation': 'Constantin JM, Jaber S, Futier E, Cayot-Constantin S, Verny-Pic M, Jung B, Bailly A, Guerin R, Bazin JE. Respiratory effects of different recruitment maneuvers in acute respiratory distress syndrome. Crit Care. 2008;12(2):R50. doi: 10.1186/cc6869. Epub 2008 Apr 16.'}, {'pmid': '18514825', 'type': 'BACKGROUND', 'citation': 'Rangel-Castilla L, Gopinath S, Robertson CS. Management of intracranial hypertension. Neurol Clin. 2008 May;26(2):521-41, x. doi: 10.1016/j.ncl.2008.02.003.'}, {'pmid': '17127126', 'type': 'BACKGROUND', 'citation': 'Chesnut RM. Care of central nervous system injuries. Surg Clin North Am. 2007 Feb;87(1):119-56, vii. doi: 10.1016/j.suc.2006.09.018.'}, {'pmid': '20197533', 'type': 'BACKGROUND', 'citation': 'Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.', 'detailedDescription': 'Two ARM are compared in this study:\n\n* The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cm H2O with decrease of tidal volume (Vt) if necessary.\n* The continuous positive airway pressure, or Continuous Positive Airway Pressure (CPAP) with application of a positive pressure of 40 cm H2O for 40 seconds without tidal volume.\n\nPatients are randomized to receive in cross-over 2 ARM: CPAP and Extended Sigh (eSigh). The following data: oxygen tissue partial pressure (PtiO2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke)\n* Patients with moderate and severe ARDS criteria (as defined by classification of Berlin)\n* Patients under mechanical ventilation\n\nExclusion Criteria:\n\n* ICP (Intracranial pressure) \\> 25 mmHg\n* Pregnant women\n* Patients with history of chronic respiratory disease\n* Patients with bronchopleural fistula\n* Patients with hemodynamic instability despite appropriate measures'}, 'identificationModule': {'nctId': 'NCT02574169', 'acronym': "M'RHICO", 'briefTitle': 'Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation', 'orgStudyIdInfo': {'id': 'RC31/15/7604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alveolar recruitment maneuvers Group 1', 'description': 'alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh', 'interventionNames': ['Other: alveolar recruitment maneuvers group 1']}, {'type': 'EXPERIMENTAL', 'label': 'Alveolar recruitment maneuvers Group 2', 'description': 'alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP', 'interventionNames': ['Other: alveolar recruitment maneuvers group 2']}], 'interventions': [{'name': 'alveolar recruitment maneuvers group 1', 'type': 'OTHER', 'description': 'Patients are randomized to receive in cross-over 2 ARM: CPAP at first and then eSigh.\n\nThe continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume.\n\nThe eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary.\n\nThe following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.', 'armGroupLabels': ['Alveolar recruitment maneuvers Group 1']}, {'name': 'alveolar recruitment maneuvers group 2', 'type': 'OTHER', 'description': 'Patients are randomized to receive in cross-over 2 ARM: eSigh at first and then CPAP.\n\nThe eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary.\n\nThe continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume.\n\nThe following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.', 'armGroupLabels': ['Alveolar recruitment maneuvers Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'Midi Pyrénées', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ségolène MROZEK, MD', 'role': 'CONTACT', 'email': 'mrozek.s@chu-toulouse.fr', 'phone': '05 61 77 21 67', 'phoneExt': '+33'}, {'name': 'Thomas GEERAERTS, MD', 'role': 'CONTACT', 'email': 'geeraerts.t@chu-toulouse.fr', 'phone': '05 61 77 21 00', 'phoneExt': '+33'}, {'name': 'Ségolène MROZEK, MD', 'role': 'CONTACT'}, {'name': 'Thomas GEERAERTS, MD', 'role': 'CONTACT'}, {'name': 'Béatrice RIU, MD', 'role': 'CONTACT'}], 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '140033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc-Olivier FISCHER, MD', 'role': 'CONTACT', 'email': 'marcolivierfischer@yahoo.fr', 'phone': '02 31 06 33 03', 'phoneExt': '+33'}], 'facility': 'UH Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rusell CHABANNE, MD', 'role': 'CONTACT', 'email': 'rchabanne@chu-clermontferrand.fr', 'phone': '04 73 75 16 48', 'phoneExt': '+33'}, {'name': 'Jean-Michel CONSTANTIN, MD', 'role': 'CONTACT', 'email': 'jmconstantin@chu-clermontferrand.fr', 'phone': '04 73 75 05 01', 'phoneExt': '+33'}], 'facility': 'UH Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-François PERRIGAUT', 'role': 'CONTACT', 'email': 'pf-perrigault@chu-montpellier.fr', 'phone': '04 67 33 76 87', 'phoneExt': '+33'}], 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine ROQUILLY, MD', 'role': 'CONTACT', 'email': 'antoine.roquilly@gmail.com', 'phone': '02 40 08 30 08', 'phoneExt': '+33'}], 'facility': 'UH Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Ségolène MROZEK, MD', 'role': 'CONTACT', 'email': 'mrozek.s@chu-toulouse.fr', 'phone': '05 61 77 21 67', 'phoneExt': '+33'}, {'name': 'Audrey Tomasik', 'role': 'CONTACT', 'email': 'tomasik.a@chu-toulouse.fr', 'phone': '05 61 77 85 97'}], 'overallOfficials': [{'name': 'Ségolène MROZEK, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH TOULOUSE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}