Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-29 @ 1:01 PM
Study NCT ID:
NCT07090460
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing inter-lungs insufflation delay under NIV or invasive mechanical ventilation on the impedance-time curves without PEEP.', 'timeFrame': 'Only 1 visit'}], 'secondaryOutcomes': [{'measure': 'Assessing inter-lungs insufflation delay under NIV or invasive mechanical ventilation on the impedance-time curves with PEEP.', 'timeFrame': 'Only 1 visit'}, {'measure': 'Comparison of End Expiratory Lung Impedance with or without PEEP', 'timeFrame': 'Only 1 visit'}, {'measure': 'Post treatment analysis of EIT low flow PV curves in intubated sedated patients, measurement of each lung PEEPi', 'timeFrame': 'Only 1 visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Mechanical Ventilation', 'NIV', 'Asynchronies', 'Electrical Impedance Tomography', 'Pressure Impedance curve'], 'conditions': ['Acute Respiratory Distress Syndrome (ARDS)']}, 'descriptionModule': {'briefSummary': 'Mechanical ventilation in COPD requires a good interaction Patient-Ventilator without asynchronies in order to reduce mortality. Dynamic hyperinflation with PEEPi is responsible for major asynchronies in COPD. It is supposed to be symmetrical between the 2 lungs with the same PEEPi. EIT can measure the distribution of tidal ventilation and interlung lung insufflation delay on the impedance time curve of each lung. Moreover, it is possible in intubated COPD patients to assess one lung PEEPi during low flow insufflation with pressure-EIT monitoring.\n\nThis study aims to measure interlungs insufflation delay under mechanical ventilation in COPD patients', 'detailedDescription': 'Scientific justification: Moderate or severe COPD with respiratory acidosis requires mechanical ventilation whether it is non-invasive or after intubation. There is a risk of various asynchronies due to dynamic hyperinflation, and it has been shown that a high level of asynchronies can be associated with mortality. EIT can measure the regional distribution of tidal ventilation, and its timing. It can also measure unilateral Pressure-EIT curves with low inflection point representing PEEPi.\n\nStrategy description: Patients with moderate or severe COPD treated with mechanical ventilation equipped with EIT will be included. EIT will be monitored during tidal ventilation and during PEEP titration by the attending physician as it is already done in our unit. In case of invasive ventilation (NIV failure), a classical low flow PV curve will be done in order to mesure one lung PEEPi. For that the acquisition of EIT data during the low flow PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional PEEPi.\n\nFollow up description:\n\n* Measurement of EIT data and ventilator spirometry during NIV initiation and PEEP titration.\n* Blood gases under NIV as usual\n* Hemodynamic data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Acute Respiratory Distress Syndrom in prone position', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized in the ICU and who suffered moderate or severe COP (Gold 3 and 4)), with respiratory acidosis under NIV or intubated, and equipped with EIT over the age of 18.\n\nExclusion Criteria:\n\n* Broncho-pleural leaks\n* Pregnant or breastfeeding woman.\n* Guardianship or curatorship\n* Deprived of liberty\n* No health insurance\n* Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)\n* Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)'}, 'identificationModule': {'nctId': 'NCT07090460', 'acronym': 'Tomo-BPCO', 'briefTitle': 'Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de la côte Basque'}, 'officialTitle': 'Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.', 'orgStudyIdInfo': {'id': 'P-2025/01'}, 'secondaryIdInfos': [{'id': '2025-A00447-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64109', 'city': 'Bayonne', 'state': 'Centre Hospitalier de La Côte Basque', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Séverine LABARRERE', 'role': 'CONTACT', 'email': 'slabarrere@ch-cotebasque.fr', 'phone': '0559443828'}, {'name': 'Hadrien ROZE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}], 'centralContacts': [{'name': 'Professor ROZE', 'role': 'CONTACT', 'email': 'hroze@ch-cotebasque.fr', 'phone': '+33559443535'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de la côte Basque', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr ROZE Hadrien', 'investigatorFullName': 'LABARRERE Séverine', 'investigatorAffiliation': 'Centre Hospitalier de la côte Basque'}}}}